MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-03 for ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM 11.1002 manufactured by Conmed Corporation.
[129045345]
To date, the reported device has not been received at conmed for evaluation. Should the device be returned, an evaluation will be performed. Upon completion of the complaint investigation a supplemental and final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[129045346]
The conmed sales representative reported on behalf of their customer that the alligator grasper, straight, 3. 4mm x 130mm item # 11. 1002, serial # (b)(4) device broke during a knee arthroscopic procedure to remove a loose body on (b)(6) 2018. The surgeon performed the arthroscopy and located the bony loose body fragment to remove from knee joint. After approximately 30-40minutes into the procedure, the surgeon introduced the grasper and grabbed the fragment. When he tried to remove the loose body, there was an audible snap and the lower half of the jaw on the grasper was gone. He spent an hour searching the joint with an arthroscopic camera and assistance of fluoroscopy. The alligator grasper lower jaw fragment was located but in a very difficult area to reach in posterior medial portion of knee. The grasper fragment kept drifting deeper and deeper until it was no longer in view and lodged in soft tissues on the posterior medial portion of knee. The surgeon, then fearing more damage to the knee from searching, decided to stop the procedure. The surgery was delayed by the 1 hour mentioned. This report is being raised on the basis of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00177 |
| MDR Report Key | 8124529 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-03 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2019-01-04 |
| Device Manufacturer Date | 2003-11-14 |
| Date Added to Maude | 2018-12-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal | 337734908 |
| Manufacturer Phone | 7273995557 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337734908 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM |
| Generic Name | FORCEPS, DISSECTING |
| Product Code | GEN |
| Date Received | 2018-12-03 |
| Catalog Number | 11.1002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 337734908 US 337734908 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-03 |