MAUDE Adverse Event Report: CONMED CORPORATION UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT HAND CONTROL HANDLE, E/S, S/I; UNIVERSAL PLUS PISTOL GRIP

Catalog Number	60-6010-002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2015
Additional Manufacturer Narrative
One (1) "used/damaged"60-6010-002 universal plus multifunction instrument hand control handle, electrosurgical, suction/irrigation device was returned for evaluation.The blue esu cable had been cut in half and the esu plug was not returned.To check for continuous operation, the proximal blue cable insulation was stripped to expose bare wire.A sample universal plus l-hook electrode was then attached to the handle.Using a calibrated electrical multimeter, electrical connections were made between the distal end of the electrode and the ground, cut, and then coag wires.The ground correctly showed continuity with no buttons pressed.No continuity was observed in coag or cut modes with no buttons pressed.When the buttons were pressed, continuity was observed in both coag and cut modes.It was noted that the coag and cut button dome switches toggled on and off smoothly with no sticking.These results were reproduced during several repetitions.The handle was dismantled for examination.No anomalies were observed.However, a complete evaluation of the device could not be accomplished as part of the esu cord and the esu plug were failed to be returned by the end-user.In this instance, the partial device that was returned exhibited no manufacturing defects and this partial device performed to specifications electrically.The investigation could not be reproduced with the returned partial device.This device was manufactured 06-may-2015.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident.Of the lot containing (b)(4) units, there were no other similar complaints received.A two (2) year review of product history for this device group, universal plus pistol grip handle devices, showed a total of three (3) similar complaints of alleged self-activation.During this same two (2) year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this reported failure mode (b)(4) percent.It should be noted that with all three (3) of these reported incidents, none of the alleged failure modes of self-activation could be confirmed.Also, to date, there have been no reported patient injuries, or, no patient long term adverse effects reported regarding any of the reported incidents.The universal plus multifunction instrument hand control handle, electrosurgical, suction/irrigation device is a dissecting instrument with suction/irrigation channels within the instrument shaft for use in surgical endoscopic procedures such as laparoscopy, pelviscopy, and thoracoscopy.To reduce the risk of patient injury, the instructions for use (ifu) provides the following cautions and warnings: 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.Always use the lowest possible power setting to achieve the desired electrosurgical effect.Do not activate the electrosurgical unit if the tip of the instrument is within the trocar cannula, or when not in contact with the target tissue or in position to deliver energy (fulguration) to target tissue.Doing so may cause burns to the patient.Do not activate the electrosurgical unit when irrigating through the instrument.Improper use of this or any electrosurgical device can result in a patient injury.Read and become familiar with all instructions and directions before using this device.
Event or Problem Description
On (b)(6) 2015, a universal plus multifunction instrument hand control handle, electrosurgical, suction/irrigation was being utilized in a surgical procedure.As reported, the device functioned normally at the beginning of the procedure; however, then the coag was staying on continuously, presumably without the button being pushed.End-user "cut" the cord to deactivate the device.A second universal plus multifunction instrument hand control handle was utilized to complete the procedure without any surgical delay or patient injury.There has been no additional information received regarding the patient's latest condition or indication that any long term adverse effect had occurred.

• Brand Name: UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT HAND CONTROL HANDLE, E/S, S/I
• Common Device Name: UNIVERSAL PLUS PISTOL GRIP
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5388178
• Report Number: 3007305485-2015-00038
• Device Sequence Number: 229572
• Product Code: GEI
• UDI-Device Identifier: 00653405011708
• UDI-Public: (01)00653405011708(17)200119(30)1(10)201505064
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Report Date (Section B): 12/28/2015

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: 05/04/2020
• Device Catalogue Number: 60-6010-002
• Device Lot Number: 201505064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 61