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

Catalog Number	00230A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the spider net was unable to be performed due to the device being discarded at the facility.A root cause is therefore unable to be determined.A total of (b)(4) units were manufactured in this lot.Of those, this is the only complaint against the lot.A historical complaint review was completed and 5 similar complaints for this device family have been reported.In that same timeframe, (b)(4) units have been manufactured and sold worldwide, making the rate of occurrence of this failure (b)(4).A review of the manufacturing documents, device history record, show no abnormalities that could cause or be related to this alleged malfunction.The products released for distribution were found to have met all specifications prior to shipment.The instructions for use mitigate this reported failure by way of the following cautions.-the device is not intended to be used for severing tissue or polyps and is not intended to be connected to an electrosurgical device to provide cautery.-to prevent inadvertent injury of perforation od internal organs and body structures, retrieval should be performed under direct endoscopic vision.-retrieval nets should only be used by or under the supervision of physicians thoroughly trained in polypectomy and gastrointestinal endoscopy.-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.This issue will continue to be monitored through the complaint system.
Event or Problem Description
The user facility reported a 00230a specimen bag broke during the removal of a food bolus.This caused a five minute surgical delay and a second net from the same lot was used to complete the surgery successfully.There was no patient injury or issues reported.The device was discarded at the facility in the main o.R.; therefore, it will not be returned for evaluation.Additional patient information was not able to be obtained.This incident will be reported as a device 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: 6829673
• Report Number: 1320894-2017-00197
• Device Sequence Number: 19012117
• Product Code: FGX
• UDI-Device Identifier: 10653405054122
• UDI-Public: (01)10653405054122(17)190612(10)201706121
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: 06/12/2019
• Device Catalogue Number: 00230A
• Device Lot Number: 201706121
• 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: 08/18/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1