MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for RANEY CLIP N/A FFP013P manufactured by Aesculap, Inc..
[67860001]
Patient Sequence No: 1, Text Type: N, H10
[67860002]
We opened a pack of raney clips (lot#52274399) and determined the clips would not appropriately fire with any of the 4 clip appliers. We opened a different package (lot#52153841) and all 4 raney clip appliers functioned appropriately. I then grabbed another 2 packages of raney clips, one with a completely different lot # (52187385), and one with the same "bad" lot (52274399). The lot# 52187385 fired correctly with every clip applier. The lot#52274399 did not fire correctly with any of the 4 clip appliers. It was determined that the issue of misfire was not because of broken clip appliers, but of a bad lot# with the clips. Lead and manager of service line informed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6345873 |
| MDR Report Key | 6345873 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-18 |
| Date of Event | 2017-01-12 |
| Report Date | 2017-01-18 |
| Date Reported to FDA | 2017-01-18 |
| Date Reported to Mfgr | 2017-01-18 |
| Date Added to Maude | 2017-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | RANEY CLIP |
| Generic Name | CLIP, SCALP |
| Product Code | HBO |
| Date Received | 2017-02-21 |
| Model Number | N/A |
| Catalog Number | FFP013P |
| Lot Number | 52274399 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-21 |