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

Catalog Number	00230A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the user facility; therefore, the reported failure could not be verified and a root cause cannot be determined.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 during manufacture.A two-year review of complaint history revealed 5 similar complaints, with 6 devices, for this product family and failure mode.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent.A risk analysis was performed and found this failure mode and occurrence level to be acceptable and consistent with current risk documents.The instructions for use advise the user of the following.- after the object is secure in the net assembly, to gently retract the endoscope with the object in full view.- 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.- do not use this device if there is any detectable handling or shipping damage.- the ability to effectively clean this single use device has not been established and subsequent re-use may adversely affect the performance and/or safety of the device.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the user facility that during an endoscopic procedure, the 00230a spider bag broke.To date, no additional information regarding the patient or event has been made available.No patient injury was reported.This incident is raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: STANDARD NET 230L
• Common Device Name: NAKAO SPIDER-NET RETRIEVAL DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7173476
• Report Number: 1320894-2018-00005
• Device Sequence Number: 16353853
• Product Code: FGX
• UDI-Device Identifier: 00653405054125
• UDI-Public: (01)00653405054125(17)190314(10)201703141
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2018

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: Health Professional
• Device Expiration Date: 03/14/2019
• Device Catalogue Number: 00230A
• Device Lot Number: 201703141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1