MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-07-16 for MAXUM REUSABLE BIOPSY FORCEPS BBF-1.8-110 manufactured by Wilson-cook Medical, Inc..
[292336]
During the procedure, a physician used a wilson-cook maxum reusable biopsy forceps to attain a transbronchial biopsy. The forceps were inspected prior to advancement through the endoscope. One biopsy was successful. When the device was advanced to collect the second biopsy, a portion of one cut was missing. The pt was given washouts and a chest x-ray. However, the missing portion of the cup was unable to be located. An injury to the pt was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2003-00046 |
| MDR Report Key | 472682 |
| Report Source | 08 |
| Date Received | 2003-07-16 |
| Date of Report | 2003-06-16 |
| Date of Event | 2003-05-16 |
| Date Mfgr Received | 2003-06-16 |
| Date Added to Maude | 2003-07-22 |
| 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, MANAGER |
| 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 REUSABLE BIOPSY FORCEPS |
| Generic Name | REUSABLE BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 2003-07-16 |
| Returned To Mfg | 2003-06-30 |
| Model Number | NA |
| Catalog Number | BBF-1.8-110 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 461535 |
| 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 | 2003-07-16 |