MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-12 for CORE TROCARS CD612 manufactured by Conmed Corporation.
[129161900]
The alleged broken cd612 is not expected to be returned for evaluation and review. This complaint of broken device is unable to be verified and a root cause cannot be determined. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution was found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the past two years. A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 18 devices, for this device family and failure mode. During this same time frame 168,092 devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following: insert the appropriate size entree plus trocar or core audible trocar into the cannula. Warnings and precautions: procedure for endoscopic surgery should be performed only qualified and trained physicians familiar with endoscopic surgical technique. To prevent damage, the trocar should not be introduced into the cannula valve at an angle. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[129161901]
The sales representative reported on behalf of the customer that the cd612 device valve membrane ripped and fell into the patient cavity upon introduction of instrument into the valve and cannula during a procedure on (b)(6) 2018. This caused a 5-minute delay while the component was removed by graspers. There was no report of patient injury during this event. There was no reported medical intervention or extended hospital stay for the patient per the reporter. Based on the information available, and the decision tree results, this complaint does meet the definition of a reportable event. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00245 |
| MDR Report Key | 8059296 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-12 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2019-01-04 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2018-11-12 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE TROCARS |
| Generic Name | CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE |
| Product Code | FBM |
| Date Received | 2018-11-12 |
| Returned To Mfg | 2019-01-03 |
| Catalog Number | CD612 |
| Lot Number | 201807311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-12 |