MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-02 for GRASPING FORCEPS, OPTICAL, FOR 12? AND 30? TELESCOPE A20718A manufactured by Olympus Winter & Ibe Gmbh.
[126012416]
The device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determined at this time. As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The instruction manual warns users? Before use - operate the handle. Make sure that the jaws open and close smoothly.? In addition, the original equipment manufacturer (oem) performed a manufacturing and quality control review for the last 24 months of production and found no non-conformities or deviations related to the reported issue. A review of the device history record could not be performed as the reporter provided an incorrect serial/ lot number. In an effort to mitigate this type of forcep malfunction the oem recommends that the stone punch be used to crush stones and not the a20718a that is intended for grasping objects in the bladder like ureteral stents, not for crushing stones.
Patient Sequence No: 1, Text Type: N, H10
[126012417]
Olympus was informed that during an unspecified procedure, the forceps became locked in the open position and damaged the patient? S urethra. It is unknown if the intended procedure was completed or if the patient was treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00670 |
| MDR Report Key | 8034930 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-11-02 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-11-02 |
| 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 | GRASPING FORCEPS, OPTICAL, FOR 12? AND 30? TELESCOPE |
| Generic Name | GRASPING FORCEPS |
| Product Code | GCP |
| Date Received | 2018-11-02 |
| Returned To Mfg | 2018-11-19 |
| Model Number | A20718A |
| Catalog Number | A20718A |
| Lot Number | 183W-0007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-02 |