MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-09-08 for CYSTOURETHROSCOPE STANDARD OBTURATOR, 21FR E121-O manufactured by Gyrus Acmi Inc,.
[25223184]
The referenced device was returned to olympus for evaluation. The evaluation confirmed the obturator tip was broken. This type of obturator damage is most likely due to touching a metallic or hard object during handling or storage. The instruction manual warns users "prior to each use, examine any electrode or other ancillary device/accessory and its insulation for damage; do not use if damaged. "
Patient Sequence No: 1, Text Type: N, H10
[25223185]
Olympus was informed that during set-up of the operating room and before the start of the unspecified procedure, the obturator tip broke off. It was reported that no device fragments fell inside the patient. The intended procedure was completed with a similar device. There was no patient injury reported. The patient was discharged home the same day. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2015-00423 |
| MDR Report Key | 5062194 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-08 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-08-20 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-09-08 |
| 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 | MRS. NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYSTOURETHROSCOPE STANDARD OBTURATOR, 21FR |
| Generic Name | STANDARD OBTURATOR |
| Product Code | FEC |
| Date Received | 2015-09-08 |
| Returned To Mfg | 2015-08-24 |
| Model Number | E121-O |
| Catalog Number | E121-O |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC, |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 018822104 US 018822104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-08 |