MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-22 for PROBE MAJ-985 manufactured by Olympus Medical Systems Cooperation.
[65460965]
The subject devices were returned to omsc for investigation. Returned devices were one maj-984 and two maj-985s. There was no report which maj-985 was related to the phenomenon. There were scratches at the tips and the middle positions of all subject devices. We consider that these scratches at the middle were likely to be caused by the scope having touched to the probe activating output. The tiny shards of metal were caused when the scope touched to the probe activating output. It might have related to improper user handling. Almost all of the tiny shards of metal will be collected by irrigation fluid flow. Also, olympus states the appropriate handling of the maj-984, maj-985 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 8010047-2017-10041, 8010047-2017-10043.
Patient Sequence No: 1, Text Type: N, H10
[65460966]
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 customer reported that on 2 recent occasions of nephron-lithotripsy using lus-2 along with the maj-984 and maj-895 probes, they have experienced very tiny shards of metal coming off the probes into the patient. The lus-2 & maj-984 probes are being used in conjunction with a wolf short nephroscope with 4mm channel. There was no patient injury reported. This mdr is to account for one case using the subject maj-985 (first one).
Patient Sequence No: 1, Text Type: D, B5
[68481154]
The subject devices were returned to omsc for investigation. Returned devices were one maj-984 and two maj-985s. There was no report which maj-985 was related to the phenomenon. There were scratches at the tips and the middle positions of all subject devices. We consider that these scratches at the middle were likely to be caused by the scope having touched to the probe activating output. The tiny shards of metal were caused when the scope touched to the probe activating output. It might have related to improper user handling. Almost all of the tiny shards of metal will be collected by irrigation fluid flow. Also, olympus states the appropriate handling of the maj-984, maj-985 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 8010047-2017-10040, 8010047-2017-10041. This is a supplemental report for mfr report #8010047-2017-10042 to correct cross reference mfr. Report numbers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2017-10042 |
| MDR Report Key | 6269152 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-22 |
| Date of Report | 2017-02-13 |
| Date of Event | 2012-03-26 |
| Date Mfgr Received | 2012-04-10 |
| Date Added to Maude | 2017-01-22 |
| 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 | 3 |
| Brand Name | PROBE |
| Generic Name | PROBE |
| Product Code | FEO |
| Date Received | 2017-01-22 |
| Returned To Mfg | 2012-05-28 |
| Model Number | MAJ-985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-01-22 |