MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for INNER SHEATH, FOR 27 FR. OUTER SHEATH A2641 manufactured by Olympus Winter & Ibe Gmbh.
[103832449]
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the user's experience 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
[103832450]
Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the ceramic insulation at the distal end of the inner sheath broke off and fell inside the patient. However, no fragment remained inside the patient since it was reportedly retrieved. The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2018-00031 |
| MDR Report Key | 7369264 |
| Date Received | 2018-03-26 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2004-05-04 |
| Date Added to Maude | 2018-03-26 |
| 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. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | US |
| 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 | 0 |
| Brand Name | INNER SHEATH, FOR 27 FR. OUTER SHEATH |
| Generic Name | RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS |
| Product Code | FDC |
| Date Received | 2018-03-26 |
| Model Number | A2641 |
| Catalog Number | A2641 |
| Lot Number | 44W |
| ID Number | 04042761004060 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |