MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-07 for WECK HEMOLOCK 544995L manufactured by Teleflex Medical.
[85582939]
Patient Sequence No: 1, Text Type: N, H10
[85582940]
During case, the blue wrapped clip applier malfunctioned, and was stuck on patient's vessel. The doctor had to assist with removal of the clip applier. Another clip applier was obtained with satisfactory results. Per rn in the case, "the tip appeared to be bent causing the clip to be stuck on the vessel. We do not believe it was the clips, the instrument looked damaged. It was not noticed prior to the first use because it loaded without issues". The clip applier malfunctioned on the vessel and would not release. After the instrument was removed with the assistance of the surgeon's robotic arms it was inspected. The tip looked like it may have been misaligned or slightly bent on visual inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6849241 |
| MDR Report Key | 6849241 |
| Date Received | 2017-09-07 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-06-29 |
| Report Date | 2017-08-08 |
| Date Reported to FDA | 2017-08-08 |
| Date Reported to Mfgr | 2017-08-08 |
| Date Added to Maude | 2017-09-07 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | WECK HEMOLOCK |
| Generic Name | APPLIER, HEMOSTATIC CLIP |
| Product Code | HBT |
| Date Received | 2017-09-07 |
| Catalog Number | 544995L |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-07 |