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 2020-01-07 for INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A manufactured by Olympus Winter & Ibe Gmbh.
[178781895]
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[178781896]
Olympus was informed that during a therapeutic holmium laser enucleation of the prostate (holep) procedure, the ceramic insulation at the distal end of the inner sheath broke off inside the patient. It was reported that the ceramic insulation was damaged by contact with a surgical equipment and that the fracture injured the prostate, resulting in a considerable bleeding. The procedure was then changed to a therapeutic transurethral resection of the prostate (turp) procedure and completed with a similar device. No fragment remained inside the patient since it was reportedly retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2020-00039 |
| MDR Report Key | 9557056 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 4940669662 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER SHEATH, FOR 26 FR. OUTER SHEATH |
| Generic Name | RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS |
| Product Code | FJL |
| Date Received | 2020-01-07 |
| Model Number | A22040A |
| Catalog Number | A22040A |
| Lot Number | 14ZW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2020-01-07 |