MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for USA ELITE RIGID OPTICAL GRASPING FORCEPS E8215 manufactured by Gyrus Acmi, Inc.
[93690799]
The device will not be returned to olympus for evaluation. The exact cause of the reported event cannot be determined. However, based on similar reports, the operator? S technique cannot be ruled out as a contributory factor to the reported event. The instruction manual warns user? S that? Excessive squeezing force on handles can lead to failure of forceps jaws.?
Patient Sequence No: 1, Text Type: N, H10
[93690800]
Olympus received a medwatch report that indicates during a therapeutic cystourethroscopy with holmium laser cystolitholapaxy procedure, the grasper jaw broke off and fell into the patient? S bladder. It was reported that the surgeon was removing stones when the grasper broke. The device fragments were retrieved with an unknown device. There was no bleeding reported. The intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00745 |
| MDR Report Key | 7053691 |
| Date Received | 2017-11-22 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-10-19 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2017-11-22 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | USA ELITE RIGID OPTICAL GRASPING FORCEPS |
| Generic Name | RIGID OPTICAL GRASPING FORCEPS |
| Product Code | GEN |
| Date Received | 2017-11-22 |
| Returned To Mfg | 2017-12-18 |
| Model Number | E8215 |
| Catalog Number | E8215 |
| Lot Number | EW |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |