MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2007-10-24 for OLYMPUS PCF-160AL manufactured by Olympus Medical Systems Corporation.
[734437]
The hospital reported that following a diagnostic colonoscopy, a pt reportedly underwent a successful surgical correction of the perforation, and was discharged a week later. The pt is reportedly doing fine at present. The hospital claimed that the device was inspected prior to and after the procedure. The facility reported, there were no irregularities found with the device prior to the procedure, but after the procedure the physician noted the distal tip to be slightly sharp. Olympus was informed the subject device had been used by the facility after the reported event, and no other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[7883117]
The device referenced in this report was returned to olympus for investigation. The eval noted very small dents on the air/water nozzle that felt slightly sharp to touch, which may have contributed to the user's experience. There was also a large crack found on the c-cover at the air/water nozzle area, dents on the c-cover and biopsy channel tip, but none of these were noted to have sharp edges. One of the light guide lenses and the bending section cover glue was noted to be cracked and had many scratches, but there were no sharp edges detected at these sites. There was evidence of third-party repairs on the variable stiffness control, which was also found to be non-functional. The extensive damage found on the device were attributed to physical damage. The cause of the perforation could not be conclusively determined. The device instruction manual advises users to carefully inspect the device prior to use, including running the users fingers over the device to ensure that there are no sharp edges.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00164 |
| MDR Report Key | 931616 |
| Report Source | 00,05,06 |
| Date Received | 2007-10-24 |
| Date of Report | 2007-09-14 |
| Date of Event | 2007-09-14 |
| Date Added to Maude | 2007-10-29 |
| 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 SHINUJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 16391 |
| 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 EXERA PEDIATRIC COLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-24 |
| Model Number | PCF-160AL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 905219 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-10-24 |