MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-07 for ERCP EXTRACTION BALLOON * B-V231P-B manufactured by Olympus America, Inc..
[1103641]
During ercp the distal tip of the extraction balloon broke off and went down her small bowel. It is only 1-2 cm in length and this is a flexible plastic that will pass without difficulty. Therefore, the tip was not retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1403054 |
| MDR Report Key | 1403054 |
| Date Received | 2009-06-07 |
| Date of Report | 2009-06-07 |
| Date of Event | 2009-05-05 |
| Report Date | 2009-06-07 |
| Date Reported to FDA | 2009-06-07 |
| Date Added to Maude | 2009-06-17 |
| 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 | ERCP EXTRACTION BALLOON |
| Generic Name | BALLOON, EXTRACTION, BILIARY |
| Product Code | ODD |
| Date Received | 2009-06-07 |
| Returned To Mfg | 2009-05-07 |
| Model Number | * |
| Catalog Number | B-V231P-B |
| Lot Number | 8YK |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | 3500 CORPORATE PKWY P.O. BOX 6 CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-07 |