MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-11 for CAPLIVATOR CRESENT SNARE 6236 manufactured by Microvasive.
[18037]
Snare snapped while attempting to (close) remove a polyp @ the handle end.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 26939 |
MDR Report Key | 26939 |
Date Received | 1995-08-11 |
Date of Report | 1995-02-08 |
Date of Event | 1995-01-13 |
Date Facility Aware | 1995-01-13 |
Report Date | 1995-02-08 |
Date Reported to Mfgr | 1995-01-13 |
Date Added to Maude | 1995-10-13 |
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 |
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 | CAPLIVATOR CRESENT SNARE |
Generic Name | SNARE |
Product Code | FDJ |
Date Received | 1995-08-11 |
Returned To Mfg | 1995-01-13 |
Model Number | NA |
Catalog Number | 6236 |
Lot Number | H 51756 |
ID Number | NA |
Device Availability | R |
Device Age | 4 YR |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 27722 |
Manufacturer | MICROVASIVE |
Manufacturer Address | 480 OKEASABT ST WATERTOWN MA 02172 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1995-08-11 |