MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-04-16 for TISCHLER BIOPSY FORCEPS W/LOCK 8IN MH301442WL manufactured by Integra York, Pa Inc..
[4592450]
Dealer initially reports device purchased jan 2014, and is hardly used and not sharp. It is tearing tissue, not cutting, customer not satisfied. On (b)(6) 2014 clinic nurse reports doctor was performing a colposcopy and biopsy sample. Device tore/mascerated tissue, and the sample sent to pathology not suitable for accurate results for biopsy. Doctor is very experienced, his technique was not the issue.
Patient Sequence No: 1, Text Type: D, B5
[12091538]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00017 |
| MDR Report Key | 3871658 |
| Report Source | 08 |
| Date Received | 2014-04-16 |
| Date of Report | 2014-03-19 |
| Date Mfgr Received | 2014-03-26 |
| Date Added to Maude | 2014-06-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISCHLER BIOPSY FORCEPS W/LOCK 8IN |
| Generic Name | PFM07 |
| Product Code | HAD |
| Date Received | 2014-04-16 |
| Catalog Number | MH301442WL |
| Lot Number | 25SI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-16 |