MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for OLYMPUS ENDOTHERAPY? INFLATION DEVICE FOR ENDOSCOPIC BALLOON DILATION QL? 6015 MAJ-1740 manufactured by Atrion Medical Products, Inc..
[134876403]
Physician was doing a balloon dilation of fibrotic stricture about 10 cm into the terminal ileum that the colonoscope could not pass. A colonic balloon was introduced through scope's accessory channel and used to dilate the stricture up to 11 mm. During the dilation the balloon failed and water that was used to inflate leaked from balloon. A new balloon was obtained and the dilation was performed with no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8300929 |
| MDR Report Key | 8300929 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-23 |
| Date of Event | 2019-01-22 |
| Report Date | 2019-01-23 |
| Date Reported to FDA | 2019-01-23 |
| Date Reported to Mfgr | 2019-02-04 |
| Date Added to Maude | 2019-02-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | OLYMPUS ENDOTHERAPY? INFLATION DEVICE FOR ENDOSCOPIC BALLOON DILATION |
| Generic Name | DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2019-02-04 |
| Model Number | QL? 6015 |
| Catalog Number | MAJ-1740 |
| Lot Number | 96379048 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRION MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 1426 CURT FRANCIS RD. ARAB AL 35016 US 35016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |