MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-19 for UNKNOWN manufactured by Unknown(olympus Medical Systems Corp.).
[130780829]
The devices have not been returned to omsc for evaluation. Since the serial numbers of the devices were not informed, omsc could not confirm the manufacturing history. Olympus received the request from the user facility and instructed them reprocessing method on november 27th, 2018. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[130780830]
Olympus medical systems corp. (omsc) was informed that the user facility experienced seven patients infection with multidrug-resistant pseudomonas aeruginosa (mdrp) since august 2018, and six of the seven patients undergone endoscopy. Since some of the six patients experienced endoscopic retrograde cholangiopancreatography (ercp) procedures, the user facility is suspecting the causal relationship between the infection and the endoscopy. The model names of the devices which used for each patient are unknown. As a result of the microbiological testing for the subject device by the user facility, no microbe was detected from them. The user facility is planning adenosine tri-phosphate (atp) testing for the devices. The device had been reprocessed using an olympus automated endoscope reprocessor model oer-3 (not available in the usa). It was reported that three of the six patients have already been discharged, and there is no information regarding the other three patients. Olympus is submitting mdr according to the number of the patients who were infected potentially associated with the endoscope. This is 2nd of 6 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02467 |
| MDR Report Key | 8177951 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-19 |
| Date of Report | 2019-01-24 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2018-12-19 |
| 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 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 | UNKNOWN |
| Product Code | GCQ |
| Date Received | 2018-12-19 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN(OLYMPUS MEDICAL SYSTEMS CORP.) |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-19 |