MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for BYCEP 6210 manufactured by Mansfield Boston Scientific Corporation.
[4599]
After second biopsy it was noted that the biopsy forceps wire pulled away from the handle. The forceps failed to open when trying to obtain a specimen and when removed from the patient it was noted the distal end of the forceps was unhinged. Device will be returned to company for credit/replacement. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6745 |
| MDR Report Key | 6745 |
| Date Received | 1993-08-02 |
| Date of Report | 1993-06-30 |
| Date of Event | 1993-06-24 |
| Report Date | 1993-06-30 |
| Date Reported to Mfgr | 1993-06-30 |
| Date Added to Maude | 1993-10-14 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BYCEP |
| Generic Name | FLEXIBLE ENDOMYCARDIAL BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 1993-08-02 |
| Catalog Number | 6210 |
| Lot Number | 87515 |
| ID Number | JAW 2.2MM LENGTH 100CM |
| Device Expiration Date | 1995-04-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6428 |
| Manufacturer | MANSFIELD BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-02 |