MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-04-23 for UNKNOWN manufactured by Olympus Medical System Corporation.
[106140133]
The subject device was not returned to olympus for evaluation. Oomsc could not review the manufacturing history or service record as there was no specific model and serial number provided. The cause of the reported event could not be determined. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[106140134]
Olympus medical systems corp. (omsc) was informed that after an unspecified surgical procedure, a patient suffered unspecified influence since the subject device was not sterilized prior to the procedure. It was also reported that the subject device was not sterilized because a third party supplier mixed up the subject device with another sterilized surgical endoscope during the reprocessing work. Other detailed information such as model name of the subject device was not provided olympus tried to obtain additional information without success because the initial reporter was a worker of the third party supplier and the reporter already left the supplier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00703 |
| MDR Report Key | 7450024 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-23 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-04-23 |
| 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 KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 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 | UNKNOWN |
| Generic Name | SURGICAL FLEXIBLE ENDOSCOPE |
| Product Code | NWB |
| Date Received | 2018-04-23 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-23 |