MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12? AND 30? TELESCOPE A20710A manufactured by Olympus Winter & Ibe Gmbh.
[119533428]
The device has not been returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. Despite multiple followup attempts by phone and in writing, no further information is available regarding the role or performance of the forceps device in the event, the name of the procedure, the sequence of events, whether and how the procedure was completed, the patient? S current state, or the make and model number of the stone crushing device. It has also not been confirmed if the forceps device is the same device as the stone crusher. The oem performed a review of the device history record and found no related anomalies at the time of manufacturing release. As a preventive measure, the forceps instructions for use document has pre-procedure instructions to visually inspect the product and verify manual operation. The document also states,? If the instrument is damaged or does not function properly, replace it.? The document also specifies the compatible olympus devices for use with the forceps, and states that for maintenance, the distal tip should be lubricated with olympus a0273 lubricant.
Patient Sequence No: 1, Text Type: N, H10
[119533429]
Two of 2. Olympus was informed that during an unknown procedure, the forceps device was present when a separate cystoscope sheath device became bent while inside the patient, trapping and breaking a stone crusher. All device fragments were retrieved from the patient. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00495 |
| MDR Report Key | 7843779 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-30 |
| Date Added to Maude | 2018-09-04 |
| 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 | 0 |
| Brand Name | GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12? AND 30? TELESCOPE |
| Generic Name | GRASPING FORCEPS, SINGLE ACTION |
| Product Code | GCP |
| Date Received | 2018-09-04 |
| Model Number | A20710A |
| Catalog Number | A20710A |
| Lot Number | 182W-0038 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-09-04 |