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 2008-02-13 for OLYMPUS CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[18576878]
The user facility reported that a pt visited an emergency room complaining of abdominal pain two days after undergoing a colonoscopy. The pt was diagnosed with a perforated cecum, and later had a right hemicolectomy procedure performed. The user facility reported that during the colonoscopy the endoscope worked fine, but each time they initiated the pulse of the argon beam system, the pt reportedly "jumped" and appeared to have felt the pulse. The user facility also reported that the pt was properly grounded and was verified during the procedure. The procedure was completed with the same endoscope and the pt was released with no pain.
Patient Sequence No: 1, Text Type: D, B5
[18698446]
The device referenced in this report was returned to olympus for investigation. During the investigation, the insertion tube and the distal tip cover insulation were tested; the unit passed insulation testing. The bending section cover was found cracked, and there were nicks and dents on the c-cover, which were determined to be due to physical damage. However, there were no sharp edges identified on the insertion tube. There was excessive play noted on the control knobs which was determined to be due to stretched angle wires, and the up/down control knob was noted to click with movement. The variable stiffness was determined not to be working properly due to a stretched coil wire, which was determined to be due to extended use. The cause of the user's experience cannot be conclusively determined; however, the use of other non-olympus medical devices during the procedure cannot be ruled out as an contributing factor. This report is being filed as an mdr in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00024 |
| MDR Report Key | 997223 |
| Report Source | 00,05,06 |
| Date Received | 2008-02-13 |
| Date of Report | 2008-01-16 |
| Date of Event | 2008-01-14 |
| Date Added to Maude | 2008-02-19 |
| 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, 1-CHOME SHINJUKU-KU |
| Manufacturer City | TOYKO 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 | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-02-13 |
| Model Number | CF-Q160AL |
| 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 | 967288 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 1-CHOME SHINJUKU-KU TOYKO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-13 |