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 2016-01-28 for CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR E123-O manufactured by Gyrus Acmi Inc..
[37060827]
The device referenced in this report was returned to olympus for evaluation. Visual inspection confirmed the reported complaint for the tip missing/breaking off the distal end of the device. The detached fragment was not returned with the endoscope obturator. The size of the missing fragment is approximately 25mm length, 6mm width, 4mm thick and slightly angled at the tip. The returned device had scratches and minor dents along the shaft and a slight bend at the distal tip. This type of damage is most likely related to the operator's technique. The instructions manual contains several warning statements in an effort to prevent damage to the device. "upon receipt, examine the instrument and accessories for damage. Do not use a damaged product. Keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active. Prior to each use, examine any electrode or other ancillary device/accessory and its insulation for damage; do not use if damaged. Examine this device prior to use. Do not use if damage is found. " if additional information or if the missing fragment is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[37060828]
Olympus was informed that during an unspecified procedure, it was noticed that the tip was missing from the device. The patient was examined using a ct scan to verify if the tip had fallen inside the patient. The ct scan results returned negative. There was no patient injury reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00009 |
| MDR Report Key | 5397790 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-29 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-11 |
| Date Added to Maude | 2016-01-28 |
| 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 | MR. DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355161 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR |
| Generic Name | ENDOSCOPE OBTURATOR |
| Product Code | FEC |
| Date Received | 2016-01-28 |
| Returned To Mfg | 2016-01-18 |
| Model Number | E123-O |
| Catalog Number | E123-O |
| Lot Number | DM |
| 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 | 2016-01-28 |