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 2020-03-25 for DISSECTING KITTNER 40CM CD801 manufactured by Conmed Corporation.
[187567649]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[187567650]
The conmed representative reported on behalf of their facility that the cd801, laparoscopic kittner, became detached from the probe during a laparoscopic hysterectomy on (b)(6) 2020. The detached sponge tip was retrieved using graspers. There was only minutes described as the delay. There was no patient injury or impact. This report is being raised based on device malfunction with the potential of injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00123 |
| MDR Report Key | 9878456 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2020-01-27 |
| Date Added to Maude | 2020-03-25 |
| 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 | MELANIE LANNON |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISSECTING KITTNER 40CM |
| Generic Name | LAPAROSCOPIC BLUNT DISSECTOR |
| Product Code | GCJ |
| Date Received | 2020-03-25 |
| Catalog Number | CD801 |
| Lot Number | 202001271 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |