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 2019-04-04 for STANDARD NET 230L 10 PACK 00230A manufactured by Conmed Corporation.
[141030030]
The alleged ripped 00230a is not expected to be returned for evaluation and review. This complaint of ripped 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 (b)(4)complaints, regarding (b)(4) devices, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped (b)(6). 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: contraindications: this device is not intended to be used for severing tissue or polyps and is not intended to be connected to an electrosurgical device to provide cautery. This device is not mri compatible. Warning: this device is not recommended for the capture of sharp objects. When capturing foreign bodies and polyps, be sure to avoid capturing mucosa or anatomy not intended for retrieval. When retrieving objects through the esophagus, be sure to keep gentle tension on the device handle to avoid dislodgement, loss of object and/or aspiration into the trachea. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[141030031]
The sales representative reported on behalf of the customer that the 00230a, standard net 230l 10 pack, device net ripped and there was no patient or user injury. Further assessment information was requested; however, the reporter responded that they have advised all the information they can. No further information regarding this event was available. 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 | 1320894-2019-00101 |
| MDR Report Key | 8483660 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-09-17 |
| Date Added to Maude | 2019-04-04 |
| 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 | STANDARD NET 230L 10 PACK |
| Generic Name | SNARE, NON-ELECTRICAL |
| Product Code | FGX |
| Date Received | 2019-04-04 |
| Model Number | 00230A |
| Catalog Number | 00230A |
| Lot Number | 201809171 |
| 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 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |