MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for COMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR A37026A manufactured by Olympus Winter & Ibe Gmbh.
[182429451]
The service center was informed that a patient contracted a pseudomonas infection after undergoing an unspecified procedure with the cystoscope. The user facility reported that there was blood in the patient? S urine. The patient? S course of treatment is unknown. As part of our investigation , the service center followed up with the customer to obtain additional information regarding the reported event and was informed that the source of the infection has not been determined as an investigation is ongoing. In addition, an endoscopy support specialist (ess) was dispatched on (b)(4) 2020, to observe the user facility? S reprocessing methods and provide an in-service. The ess reported that there were no reprocessing deviations noted with the facility? S reprocessing practices. However, an in-service was provided that included reprocessing training, brushing, flushing and sterilization. The scope was returned to the service center and is pending physical evaluation and microbial testing. The scope will be sent to an independent laboratory for microbial testing. This is 2 of 2 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00356 |
| MDR Report Key | 9801497 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Facility Aware | 2020-02-12 |
| Report Date | 2020-02-13 |
| Date Reported to Mfgr | 2020-02-13 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR |
| Generic Name | COMPACT CYSTOSCOPE |
| Product Code | GCP |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-10 |
| Model Number | A37026A |
| Catalog Number | A37026A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |