MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-19 for PROBE MAJ-984 manufactured by Olympus Medical Systems Cooperation.
[65676114]
The subject device was returned to okm ((b)(4)) for investigation. Okm investigated the subject device and found that there was friction mark observed on the subject device and on another maj-984 used during the procedure. It was reported that the facility used a non-olympus nephroscope with the subject device. According to the pictures from okm, it was found that the non-olympus nephroscope was bent a little. From the fact that the nephroscope was bent and its channel was also bent, the subject maj-984 might have activated the ultrasonic output contacting to the channel of the nephroscope and the subject maj-984 might have fractured by the friction at the contact point. The physician continued the procedure for 1 hour in the above condition, and might have been burned from the high temperature irrigating fluid due to the friction heat at the contact point. Also, olympus states the appropriate handling of the maj-984 and the counter-measures against the irregularity in the instruction manual. There were no further details provided. If significant additional information is received, this report will be supplemented. Cross reference mfr. Report number 8010047-2017-10039.
Patient Sequence No: 1, Text Type: N, H10
[65676115]
Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this report is required. Omsc was informed of the following; a physician performed a lithotripsy of a large staghorn stone with a lus-2, a non-olympus nephroscope and the subject maj-984. After approximately 1 hour into the procedure, the subject maj-984 fractured in the channel of the nephroscope. The physician withdrew the nephroscope and the subject device was retrieved. The subject maj-984 did not fall into the patient and there was no patient injury. The physician's hand was burnt when it contacted the irrigating fluid which was very hot. The physician completed the procedure using another maj-984. This mdr is to account for the subject maj-984's fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-10038 |
| MDR Report Key | 6265542 |
| Date Received | 2017-01-19 |
| Date of Report | 2017-01-20 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-07-27 |
| Date Added to Maude | 2017-01-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROBE |
| Generic Name | PROBE |
| Product Code | FEO |
| Date Received | 2017-01-19 |
| Model Number | MAJ-984 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS COOPERATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-19 |