MAUDE Adverse Event Report: CONMED CORPORATION STANDARD NET 230L 20 PACK; NAKAO SPIDER-NET RETRIEVAL DEVICE

Catalog Number	0230AM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned; therefore a root cause of the incident was not determined.A two-year review of complaint history disclosed two similar complaints involving three devices.None of these were confirmed device failures.During the same time-frame, (b)(4) units have been shipped worldwide.A risk analysis was performed and the risk level was determined to be acceptable.A review of the manufacturing documents from the device history record has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.To reduce the risk of injury to the patient, the instructions for use advise the following: -while 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 complete retraction via the specimen protection collar, as this will crush the specimen and possibly damage the net and/or sheath.-after the object is secure in the net assembly, gently retract the endoscope with the object in full view.The reported problem will continue to be monitored through the complaint system to ensure product safety.
Event or Problem Description
The customer reported that during use the nakao spider net broke and the sample (polyp) was disrupted during surgery.This prohibited the anatomy-pathological assessment of the polyp.Multiple colon-scoping controls were required.Despite the attempt to obtain additional patient/event information, there has been no additional information received regarding the patient's demographic information or the reported incident.The device has been discarded by the user facility.This report is raised on the basis of potential injury with recurrence.

• Brand Name: STANDARD NET 230L 20 PACK
• Common Device Name: NAKAO SPIDER-NET RETRIEVAL DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6703939
• Report Number: 1320894-2017-00161
• Device Sequence Number: 19275426
• Product Code: FGX
• UDI-Device Identifier: 00653405054118
• UDI-Public: (01)00653405054118(17)181003(10)201610031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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: 10/03/2018
• Device Catalogue Number: 0230AM
• Device Lot Number: 201610031
• 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: 06/14/2017
• Initial Report FDA Received Date: 07/11/2017
• Patient Sequence Number: 1
• Patient Age: 68 YR