MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-09 for DISPOSABLE RADIAL JAW BIOSPY FORCEP 1266 manufactured by Symbiosis.
[1335]
While performing a pulmonary biospy the handle of the biopsy forceps locked in the open position hindering removal of the device from the bronchoscope. The scope and forceps were removed as a unit without incident. However, upon inspection of the forceps one cup of one of one jaw appeared missing. Bronchoscopy allowed visualization of the jaw segment within the bronchus. An attempt at retreival, utilizing grasping forceps via the bronchoscope and no complications ensued from this incidentdevice labeled for single use. Patient medical status prior to event: unknown. 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. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219544-1992-00018 |
| MDR Report Key | 1704 |
| Date Received | 1992-11-09 |
| Date of Report | 1992-10-05 |
| Date of Event | 1992-09-29 |
| Date Facility Aware | 1992-09-29 |
| Report Date | 1992-10-05 |
| Date Reported to FDA | 1992-10-05 |
| Date Reported to Mfgr | 1992-10-05 |
| Date Added to Maude | 1992-11-13 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE RADIAL JAW BIOSPY FORCEP |
| Generic Name | BIOSPY FORCEP |
| Product Code | BWH |
| Date Received | 1992-11-09 |
| Catalog Number | 1266 |
| Lot Number | 2070669A |
| Device Expiration Date | 1993-07-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-SEP-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1611 |
| Manufacturer | SYMBIOSIS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-11-09 |