MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for LAPAROSCOPIC ENDOCUT SCISSOR TIP 3142 manufactured by Stryker Sustainability Solutions.
[128749327]
During laparoscopic cholecystectomy, while utilizing the stryker sustainability, endocut scissor tip per mfr's instructions, the scissor tip would not cut. This device was replaced with a "like" item with a different lot number which worked without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081646 |
| MDR Report Key | 8110660 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-11-24 |
| Date Added to Maude | 2018-11-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LAPAROSCOPIC ENDOCUT SCISSOR TIP |
| Generic Name | SCISSORS, GENERAL, SURGICAL |
| Product Code | LRW |
| Date Received | 2018-11-27 |
| Model Number | 3142 |
| Catalog Number | 3142 |
| Lot Number | 3693883 |
| Device Expiration Date | 2019-09-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Address | TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-27 |