MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for RADIAL JAW 4 M00515180 M1518 manufactured by Boston Scientific Corp.
[107190097]
During outpatient bronchoscopy procedure biopsy forceps malfunctioned while inside the pt's left upper lobe. The jaws of the forceps stopped functioning and were frozen in the open position making it unsafe to remove without significant clinical action. A single pair of flexible biopsy forceps were used to obtain endobronchial biopsies x 5 from the mucosa of the left upper lobe. The forceps appeared to function normally with continuous video imaging. The same forceps were then used to obtain transbronchial biopsies in the left upper lobe under fluoroscopic visualization. The first biopsy appeared to be normal. On the second attempted biopsy, the respiratory therapist felt a click and the attending as well as the fellow heard a click or pop noise. On fluoroscopic imaging the biopsy forceps were noted to be stuck in the open position with the jaws angulated to one side in an abnormal orientation. It was immediately discovered that the forceps could not be withdrawn from the airway with normal force.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7477095 |
| MDR Report Key | 7477095 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-23 |
| Date Facility Aware | 2018-04-23 |
| Report Date | 2018-04-23 |
| Date Reported to FDA | 2018-04-24 |
| Date Reported to Mfgr | 2018-04-24 |
| Date Added to Maude | 2018-05-01 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RADIAL JAW 4 |
| Generic Name | SINGLE USE BIOPSY FORCEPS |
| Product Code | KGE |
| Date Received | 2018-04-25 |
| Model Number | M00515180 |
| Catalog Number | M1518 |
| Lot Number | 21521042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-25 |