MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for CONMED DURACLIP NEMOCLIP 16MM manufactured by Conmed Corp..
[119796979]
A conmed duraclip (lot # m180529231) was used during a colonoscopy. In the process of deploying the clip, a piece of metal from the tip appeared to fragment off into the pt. Attempts to retrieve the fragment from the pt's bowel were unsuccessful. Examination of the clip post deployment showed one side missing metal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079664 |
| MDR Report Key | 7859654 |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-28 |
| Date Added to Maude | 2018-09-10 |
| 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 | CONMED DURACLIP NEMOCLIP |
| Generic Name | APPLIES, HEMOSTATIC CLIP |
| Product Code | HBT |
| Date Received | 2018-09-07 |
| Returned To Mfg | 2018-08-31 |
| Model Number | 16MM |
| Lot Number | M180529231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |