MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for OES CHOLEDOCHOFIBERSCOPE CHF-P20 manufactured by Olympus Medical Systems Corp..
[69879620]
Olympus has obtained additional information that the user facility normally uses the 3 mm scope but it was being repaired, so the user facility used the subject device which has 4. 9 mm outer diameter at the distal end with a 5 mm cannula. An available next larger size of cannula was 12 mm and reportedly it would be too large for the procedure. The device referenced in this report has not been returned to olympus medical systems corp. But returned to olympus keymed (okm) for investigation. The investigation found that there was mechanical damage and water leakage. The outer layer in the insertion unit of the subject device was found to be detached from the inner tube mechanism and folded. The manufacturing record of the subject device was reviewed with no irregularity related to the phenomenon. The subject device was last serviced on (b)(6) 2016, and the insertion unit was replaced. The exact cause of the event could not be concluded at this moment but possibility the following could not be ruled out as a contributory factor of the event: concurrent use of a cannula that could not keep sufficient clearance with the subject device. If additional and significant information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[69879621]
The subject device was used for a laparoscopic common bile duct examination. The user facility reported that the damage in insertion unit of the subject device that has 4. 9 mm outer diameter, was observed upon withdrawal and the damage may have occurred as a result of using a cannula which has 5 mm inner diameter. The user facility also reported that a portion of plastic came off in the patient? S abdominal cavity but it was removed. The intended procedure has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00277 |
| MDR Report Key | 6394186 |
| Date Received | 2017-03-10 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2007-03-05 |
| Date Added to Maude | 2017-03-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OES CHOLEDOCHOFIBERSCOPE |
| Generic Name | CHOLEDOCHO FIBERSCOPE |
| Product Code | FBO |
| Date Received | 2017-03-10 |
| Model Number | CHF-P20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-10 |