MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-10-01 for OLYMPUS GF-UE160-AL manufactured by Olympus Medical Systems Corporation.
[716762]
The user facility reported that during a procedure, the balloon could not be deflated while inside the patient. The users reportedly advanced a biopsy forceps, and popped the balloon. The endoscope was then withdrawn from the patient, and a new balloon was attached to the endoscope. The procedure was completed with the same endoscope. Subsequent to the procedure, the endoscope was reprocessed and it will not be returned to olympus for evaluation. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8128869]
The device referenced in this report was not returned to olympus for investigation. Olympus representatives visited the facility to investigate the user's report of balloon not deflating. During the visit, the olympus representatives observed facility setup and reprocessing for the endoscope. Several non-conformities were observed in the reprocessing of the endoscope, which could potentially lead to a complete or partial occlusion of the balloon channel, and may have caused or contributed to the reported event. The customer was provided information on the correct reprocessing steps and olympus will follow up with additional educational resources to reduce the likelihood of recurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00140 |
| MDR Report Key | 920520 |
| Report Source | 05,06 |
| Date Received | 2007-10-01 |
| Date of Report | 2007-08-30 |
| Date Added to Maude | 2007-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, CHOME-1 |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | ULTRASONIC GASTROVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-01 |
| Model Number | GF-UE160-AL |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 905618 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-01 |