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 2018-02-12 for FLEXIBLE GRASPING FORCEP FA-558 manufactured by Lake Region Medical.
[100041605]
The device was not returned for evaluation. The exact cause of the reported event cannot be determined. The fa-558 flexible grasping forcep instruction manual warns users? Do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged. Keep instruments separate from one another to avoid damage. To ensure satisfactory performance, perform the prescribed inspections and operational tests as recommended.?
Patient Sequence No: 1, Text Type: N, H10
[100041606]
Olympus was informed that during an unspecified procedure, two of the grasping forceps used would not grasp tissue. After the surgeon withdrew the second forceps, it was noted that a screw was missing. The surgeon searched the patient's bladder with a non olympus cystoscope and was unable to locate the screw. It was reported that the surgeon believes that the screw was missing prior to use. A third forcep was used and the wire broke at the handle causing the forcep not to work. The intended procedure was completed with a fourth different device. There was no patient injury reported. Additionally, the user facility reported that post procedure the office manager searched the sterile sink for the missing screw but was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00100 |
| MDR Report Key | 7265035 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-02-12 |
| Date of Report | 2018-05-16 |
| Date Mfgr Received | 2018-04-24 |
| Date Added to Maude | 2018-02-12 |
| 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 | 3 |
| Brand Name | FLEXIBLE GRASPING FORCEP |
| Generic Name | FLEXIBLE GRASPING FORCEP |
| Product Code | GEN |
| Date Received | 2018-02-12 |
| Returned To Mfg | 2018-03-02 |
| Model Number | FA-558 |
| Catalog Number | FA-558 |
| Lot Number | 3763753 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MEDICAL |
| Manufacturer Address | 45 LEXINGTON DRIVE LACONIA NH 03246 US 03246 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-12 |