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 2020-01-09 for NAKAQ SPIDER NET RETRIEVAL DEVICE 00230A manufactured by Conmed Corporation.
[181400762]
The device will not be returned for evaluation and no photographic evidence has been provided. Therefore, the reported failure cannot be verified. A lot number was not provided; therefore, a complaint lot history or a dhr could not be reviewed. A two-year review of complaint history revealed there has been 6 complaints regarding 13 devices for this device family and failure mode. During the same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following; do not use this device if there is any detectable handling or shipping damage. Slowly test deploy net by sliding thumb ring and finger rings apart. Inspect the net for damage. Keeping the object within the net, slowly close the net by sliding the finger and thumb rings together until the net forms a pouch around the target object. Use light tension on the thumb and finger rings to ensure just enough pressure to maintain the pouch, thereby keeping the object in the net. Do not perform a complete retraction via the specimen protection collar, as this will crush the specimen and possibly damage the net and/or sheath. Do not attempt to retract the object into the working channel of the endoscope as this will crush the specimen and possibly damage the net sheath and/or endoscope.
Patient Sequence No: 1, Text Type: N, H10
[181400763]
The conmed representative reported on behalf of the facility that the 00230a, standard net, broke during a peg (percutaneous endoscopic gastronomy) tube replacement procedure on (b)(6) 2019. The tethered part of the net was detached from the wire of the device. The pressure applied outweighed the ultimate tensile strength of the device. What was left of the net was wrapped around the object they were trying to retrieve. This allowed them to capture the remaining parts of the net and object together. Another net was used to complete the surgery. There was a delay in the procedure to get another net. There was no reported patient injury or impact. This report is being raised based on device malfunction with potential for injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2019-00438 |
| MDR Report Key | 9568493 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-09 |
| 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 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| 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 | NAKAQ SPIDER NET RETRIEVAL DEVICE |
| Generic Name | STANDARD NET |
| Product Code | FGX |
| Date Received | 2020-01-09 |
| Catalog Number | 00230A |
| Lot Number | UNKNOWN |
| 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 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |