MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-04-09 for STANDARD NET 230L 10 PACK 00230A manufactured by Conmed Corporation.
[105294678]
The used device was returned to conmed with original opened product packaging. Upon visual inspection, the net of the device had a hole in it. To date, additional information regarding the patient and procedure has not been made available. A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture. A review of this lot number, with (b)(4) devices manufactured, showed no other complaint for this lot product and event description. A two-year review of complaint history revealed (b)(4) other similar complaints, with (b)(4) devices, for this product family and failure mode. In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent, if all complaints were confirmed. A risk analysis was performed and found this failure mode and occurrence level to be consistent and acceptable with current risk documents. The instructions for use advises the user of the following. Do not use this device if there is any detectable handling or shipping damage. Carefully, insert the nakao spider-net, with net retracted, into the working channel of the endoscope using short, careful strokes, until the distal end of the device sheath is seen in the field of vision. Once the object is captured in 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. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[105294679]
The distributor reported on behalf of the user facility that the 00230a standard net was used and found to be broken. To date, additional information regarding current patient status and procedure has not been made available. This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00087 |
| MDR Report Key | 7407944 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2018-04-09 |
| 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 | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD NET 230L 10 PACK |
| Generic Name | NAKAO SPIDER-NET RETRIEVAL DEV |
| Product Code | FGX |
| Date Received | 2018-04-09 |
| Returned To Mfg | 2018-03-16 |
| Catalog Number | 00230A |
| Lot Number | 201609201 |
| Device Expiration Date | 2018-09-20 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-09 |