MAUDE Adverse Event Report: CONMED CORPORATION STANDARD NET 230L 10 PACK; NAKAO SPIDER-NET RETRIEVAL DEV

Catalog Number	00230A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: STANDARD NET 230L 10 PACK
• Common Device Name: NAKAO SPIDER-NET RETRIEVAL DEV
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7407944
• Report Number: 1320894-2018-00087
• Device Sequence Number: 581305
• Product Code: FGX
• UDI-Device Identifier: 00653405054125
• UDI-Public: (01)00653405054125(17)180920(10)201609201
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/20/2018
• Device Catalogue Number: 00230A
• Device Lot Number: 201609201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1