MAUDE Adverse Event Report: CONMED CORPORATION UNIVERSAL PLUS LAPAROSCOPIC SPATULA ELECTRODE WITH ULTRA NON-STICK COATING, S/I

Catalog Number	60-5274-032
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been discarded by the end-user facility and will not be returned to conmed corporation for evaluation.Conmed is still gathering information regarding the reported event.On completion of the quality engineering evaluation a supplemental report will be filed.Discarded by end-user.
Event or Problem Description
The customer reported that while utilizing a universal plus laparoscopic spatula electrode with ultra non-stick coating, suction/irrigation lumen, in a laparoscopic ventral hernia repair, the black plastic insulation on the electrode fell off of the spatula into the patient's peritoneal cavity.The insulation coating was removed from the peritoneal cavity with no problems reported.The report further stated a second spatula with a different lot number was opened and introduced into the sterile field for surgical use.The insulation began separating from the shaft also, but that the black plastic insulation did not fall free from the device.At this point, the surgeon changed the surgical procedure from a laparoscopic case to an open ventral hernia repair due to the medical reason of complicated adhesions within the patient's peritoneal cavity.The surgical procedure was otherwise completed without further incident or patient injury.
Additional Manufacturer Narrative
As reported, the involved universal plus laparoscopic spatula electrode with ultra non-stick coating, s/i, was not expected for evaluation, as the end-user discarded the device after use.One (1) picture of the detached and retrieved spatula insulation was provided by the end-user, and, information that the insulation was not split , it was the original intact tubular shape.However, without the actual product, an evaluation could not be performed to determine a root cause of the reported event.During the manufacturing process the shrink wrap insulation is slid over the spatula until tight against the stainless steel tube.This is then shrunk by rotating the shrink wrap insulation over a heat gun.The operator then ensures the shrink tube is properly placed, fully shrunk, and tight against the stainless steel tube.The device was manufactured on 03-dec-2015.Of the lot containing (b)(4) units, there were no similar complaints received.A review of the dhr found there were no issues or abnormalities noted during the manufacturing process that could have caused or contributed to the reported problem.(b)(4).The universal plus laparoscopic spatula electrode is a single patient use electrosurgical spatula electrode with suction/irrigation capability for use in surgical endoscopic procedures.The 60-5274 series electrodes are coated with eschar-resistant coating.To ensure proper function of the universal plus laparoscopic spatula electrode and to reduce the risk of patient injury, the instruction for use (ifu) provides the following precautions and warnings: during trocar insertion, always have the electrode tip covered to avoid potential damage to trocar seals and the electrode tip.When not in use, electrosurgical instruments should be placed in a suitable holder or site which will prevent current flow to the patient should the operator accidentally activate the electrosurgical generator.Examine the device prior to use for damage.Do not use if damage is found.On the 60-5274 series, with eschar-resistant coating, any adhering can be easily wiped away with a sterile, moistened sponge.Device discarded by end-user.

• Brand Name: UNIVERSAL PLUS LAPAROSCOPIC SPATULA ELECTRODE WITH ULTRA NON-STICK COATING, S/I
• Common Device Name: SPATULA ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5484932
• Report Number: 1320894-2016-00012
• Device Sequence Number: 331987
• Product Code: GEI
• UDI-Device Identifier: 00653405010701
• UDI-Public: (01)00653405010701(17)201201(30)1(10)201512031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2016

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: 12/01/2020
• Device Catalogue Number: 60-5274-032
• Device Lot Number: 201512031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2016
• Supplement Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 127