MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-12 for OLYMPUS OPTICAL OBTURATOR A22071A manufactured by Olympus Winter & Ibe Gmbh.
[3392467]
Olympus was informed that during a bladder procedure the white ceramic distal beak of the subject device broke off and fell inside the patient. The broken piece was retrieved from the patient, and x-ray confirmed that no additional pieces were left inside the patient. The procedure was completed using other equipment and there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10594918]
Olympus followed up with the user facility in an attempt to obtain more detailed information regarding the report, but with no success. The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the user's report could not be conclusively determined at this time due to the absence of the device to investigate. If the device is received later and additional and significant information becomes available at a later time, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2013-00027 |
| MDR Report Key | 3044001 |
| Report Source | 06 |
| Date Received | 2013-03-12 |
| Date of Report | 2013-02-21 |
| Date Mfgr Received | 2013-02-21 |
| Date Added to Maude | 2013-05-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| 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 | OLYMPUS OPTICAL OBTURATOR |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2013-03-12 |
| Model Number | A22071A |
| Catalog Number | A22071A |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2013-03-12 |