MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-02-28 for OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE A22026A manufactured by Olympus Winter & Ibe Gmbh.
[140174802]
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
[140174803]
Olympus received a medwatch report which states that during an unspecified procedure, the ceramic tip from the sheath broke off and fell into the patient? S bladder. The device fragment was completely retrieved. It is unknown if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00476 |
| MDR Report Key | 8380684 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-28 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| 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 | OUTER SHEATH |
| Product Code | GCP |
| Date Received | 2019-02-28 |
| Model Number | A22026A |
| Catalog Number | A22026A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-28 |