MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-01 for OLYMPUS TJF-140F manufactured by Olympus Medical Systems Corporation.
[879923]
The user facility reported that during three therapeutic endoscopic retrograde cholangiopancreatographies, the forceps elevator of the endoscope tore the non-olympus balloons and sphincterotomes utilized with the endoscope. The procedures were reportedly completed with the same endoscope, but with other non-olympus balloons and sphincterotomes. The user facility reported there were no patient injuries.
Patient Sequence No: 1, Text Type: D, B5
[7888635]
The endoscope referenced in this report was returned to olympus for investigation. The investigation noted the presence of tech at the base of the forceps elevator, which may have caused the user's experience. The source of the damage could not be determined. The endoscope was sent to the original equipment manufacturer for further investigation. If significant, additional information becomes available, a supplemental report will be provided. This report is being filed as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00116 |
| MDR Report Key | 1073708 |
| Report Source | 05,06 |
| Date Received | 2008-07-01 |
| Date of Report | 2008-06-05 |
| Date Added to Maude | 2009-06-18 |
| 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 AVENUE |
| 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, 1-CHOME |
| 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 | EVIS DUODENOVIDEOSCOPE |
| Product Code | FAK |
| Date Received | 2008-07-01 |
| Model Number | TJF-140F |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-01 |