NA Adverse Event — Malfunction (MDR 0001056128-2020-00028)
NA Adverse Event — Malfunction (MDR 0001056128-2020-00028) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NA; Generic name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSC; Manufacturer: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND.
| Device | NA |
|---|---|
| Generic name | ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSC |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Report number | 0001056128-2020-00028 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. VISUAL INSPECTION REVEALED EVIDENCE OF EXCESSIVE BIO-BURDEN PRESENT ON THE DEVICE. MANUAL CONTINUITY TESTS WERE PERFORMED AND A SHORT WAS FOUND BETWEEN THE TWO JAWS WHEN CLOSED. THE SPACER PADS WERE INSPECTED FOR DAMAGE AND DAMAGE WAS FOUND ON ALL SPACER PADS. A REVIEW OF THE DHR FOR THE REPORTED LOT/SERIAL NUMBER SUPPORTS |
| Source | openFDA MAUDE (device adverse events) |
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