MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-19 for BIOCEPS * B-SU111-311 manufactured by Endo-therapeutics, Inc..
[3668279]
Biopsy forcep was inserted during bronchoscopy to obtain specimens. After it was opened to obtain the specimen, it would not close to grasp the specimen. The forcep was removed from the patient in the open position and then the forcep had to be cut to be removed from the bronchoscope. The patient had to have the bronchoscope reinserted, a second forcep was inserted and biopsy was obtained. No apparent harm to pt. There have been two similar events with this type of equipment at this facility in the last month. What was the original intended procedure? Bronchoscopy with biopsies. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3242181 |
| MDR Report Key | 3242181 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-07-19 |
| Date of Event | 2012-08-08 |
| Report Date | 2013-07-19 |
| Date Reported to FDA | 2013-07-19 |
| Date Reported to Mfgr | 2013-07-23 |
| Date Added to Maude | 2013-07-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BIOCEPS |
| Generic Name | FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BWH |
| Date Received | 2013-07-19 |
| Model Number | * |
| Catalog Number | B-SU111-311 |
| Lot Number | 70697 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDO-THERAPEUTICS, INC. |
| Manufacturer Address | 15251 ROOSEVELT BLVD SUITE 204 CLEARWATER FL 33760 US 33760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-19 |