MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-08-25 for UNIVERSAL ACTIVE CORD ACU-1-VL manufactured by Cook Endoscopy.
[519809]
During a polypectomy procedure a cook endoscopy universal active cord was used with another manufacturer's forceps. The physician was unable to get consistent current for a cautery application. The active cord was replaced and the procedure was able to be completed. An injury to the patient did not occur.
Patient Sequence No: 1, Text Type: D, B5
[7798561]
Evaluation: we were unable to confirm the report of difficulty with current application. Upon visual examination of the accessory connection end, it was noted the inner component has protruded 2mm from the original position, and is no longer flush with the end of the adapter. Because the accessory used with the active cord was not included in the return, an accessory from our shelf stock was connected to the active cord. The accessory connected to the active cord properly and securely. An ohmmeter was used to test electrical continuity on the active cord itself and with the accessory connected. The active cord conducted electricity both by itself and with an accessory connected. The forceps used with the active cord were not included in the return. The returned active cord was connected to hot sampler forceps from our shelf stock and a power supply unit. Power was administered (30 watts) and the cord and the forceps functioned properly. Also, a bend was noted in the cord near the accessory connection end. After a review of the device history record for this device, we can report that no discrepancies or anomalies were observed. We were unable to conduct a sample test from this lot because the devices were previously distributed. A review of the 12 mo complaint history for this product family was conducted. In the past 12 mos, there have been no other reported occurrences of difficulties with electrical current. Therefore, this incident represents an insolated occurrence. Based on this review, the likelihood of this type of occurrence is rare. The appropriate personnel were notified of this occurrence for further analysis. During this analysis, it was confirmed the inner component rec'd adhesive. A review of the device history record confirmed the product met mfg specs prior to distribution. Conclusions: movement of the inner component into the extended position did not affect active cord functionality, as described in our evaluation results. It is possible the insert had recessed at the time of use, causing intermittent cautery application. Adjustment or removal in a forceful manner could have caused the inner component to shift beyond the connector, as observed. Because the active cord was used with another manufacturer's forceps and not included in the return, we were unable to determine if the forceps may have contributed to the reported observation. The active cord was invoiced to this account on 6/1/06. We rec'd the report on 7/28/06. The useful life of a reusable device is dependent, in the large part, upon the care exercised by the user during use and general handling. A bend in the cord can occur if excessive pressure or force is applied during use/general handling. The instructions for use for the universal adapter cord instruct the user to inspect the device for kinks, bends and/or breaks. The instructions for use instruct the user to avert use when the device has been cut, burned or damaged. After a review of the twelve month complaint history for this product line, we can advise that this reported incident represents an isolated occurrence. The appropriate personnel have been notified of this occurrence for their awareness. No corrective action warranted at this time because this incident represents an isolated occurrence. The appropriate personnel have been notified of this occurrence. Customer qa will continue to monitor for trends. Prior to distribution, all universal active cords are subjected to a visual and functional inspection to ensure device integrity. The visual inspection includes verifying position of the inner component. The functional inspection includes attaching each cord to various accessory products to ensure a secure fit. The functional test also includes a test to ensure electrical continuity flow throughout the cord. A review of the device history record confirmed that this lot met mfg requirements prior to shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037905-2006-00084 |
| MDR Report Key | 776576 |
| Report Source | 06 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-07-28 |
| Date Mfgr Received | 2006-07-28 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2006-11-06 |
| 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 | 0 |
| Manufacturer Contact | MS. SHARON MILES |
| Manufacturer Street | 4900 BETHANIA STATION ROAD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367740157 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL ACTIVE CORD |
| Generic Name | MISCELLANEOUS |
| Product Code | FFZ |
| Date Received | 2006-08-25 |
| Returned To Mfg | 2006-08-11 |
| Model Number | NA |
| Catalog Number | ACU-1-VL |
| Lot Number | W2219742 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 764354 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION ROAD WINSTON-SALEM NC 27105 US |
| Baseline Brand Name | UNIVERSAL ACTIVE CORD |
| Baseline Generic Name | MISCELLANEOUS |
| Baseline Model No | NA |
| Baseline Catalog No | ACU-1-VL |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-25 |