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 2018-07-02 for OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE A22026A manufactured by Olympus Winter & Ibe Gmbh.
[112840875]
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
[112840876]
Olympus was informed that during a therapeutic transcervical resection of the endometrium in saline (tcris) procedure, the patient sustained a perforation of the uterus. It is suspected that this injury was caused by excessive force applied on the resectoscope. The procedure was then converted to a laparoscopic procedure to treat the perforation. No further information was provided but none of the olympus medical devices showed any malfunction and the procedure was reportedly completed after the intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2018-00064 |
| MDR Report Key | 7654121 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-06-22 |
| Date Added to Maude | 2018-07-02 |
| 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 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 4940669662 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE |
| Generic Name | RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS |
| Product Code | GCP |
| Date Received | 2018-07-02 |
| Model Number | A22026A |
| Catalog Number | A22026A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-07-02 |