MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-11-05 for MAXUM BIOPSY FORCEPS BBF-1.8-110 manufactured by Wilson-cook Medical, Inc..
[16295871]
During a bronchoscopy procedure, the forceps head detached from the inner drive wire and outer cable into the patient's lung. The detached portion of the device was immediately retrieved with alligator forceps. There was no adverse patient outcome reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2001-00031 |
| MDR Report Key | 359263 |
| Report Source | 05,06,07 |
| Date Received | 2001-11-05 |
| Date of Report | 2001-10-05 |
| Date of Event | 2001-09-11 |
| Date Mfgr Received | 2001-10-05 |
| Date Added to Maude | 2001-11-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JESSICA HUGHES |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXUM BIOPSY FORCEPS |
| Generic Name | BRONCHOSCOPY BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 2001-11-05 |
| Returned To Mfg | 2001-10-12 |
| Model Number | NA |
| Catalog Number | BBF-1.8-110 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 348438 |
| Manufacturer | WILSON-COOK MEDICAL, INC. |
| Manufacturer Address | 4900 BETHANIA STATION RD. WINSTON-SALEM NC 27105 US |
| Baseline Brand Name | MAXUM BIOPSY FORCEPS |
| Baseline Generic Name | BRONCHOSCOPY BIOPSY FORCEPS |
| Baseline Catalog No | BBF-1.8-110 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901348 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-05 |