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..
[3668280]
Patient was undergoing biopsies with the use of the bioceps forceps which was passed inside the bronchoscope. After a couple of biopsies were obtained, the biocep forcep was reinserted into the bronchoscope. The physician directed the respiratory therapist to open and close the forcep to obtain the specimen and when it was being closed by the respiratory therapist the physician felt as if it had popped and could feel it vibrate through the scope. The forcep was kept as closed as it could since it would not close completely. The bronchoscope had to be pulled out with the forcep and biopsy intact inside the scope. Once the forcep was out and the biopsy was removed the forcep was cut so it could be removed from the bronchoscope. No patient harm. 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 biopsy. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3242183 |
| MDR Report Key | 3242183 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-07-19 |
| Date of Event | 2013-07-15 |
| 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 | 0 |
| 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 |
| Returned To Mfg | 2013-07-19 |
| Model Number | * |
| Catalog Number | B-SU111-311 |
| Lot Number | 74023 |
| ID Number | * |
| Device Expiration Date | 2015-07-01 |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 0 |
| 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 |