MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW RIGID SHAFT HANDPIECE, 42CM, REUSABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	3925
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual inspection this complaint is confirmed.The returned handpiece was returned with obvious signs of electrical damages to the insulation.The damages to the insulation were severe, a functional test was not possible.The failure was directly through the insulation tube of the shaft.It does not appear that the failure was between the handpiece to tip connection area.The o-ring was also worn and damaged, but the damages were not the result of electrical leak.There were no burn marks or signs of electric wear due to heat.The damages noted on the shaft may have been caused by contact (in that area) with another device at some point in time.I.E.A bovie or other electrosurgical device that may have weaken the insulation in that area, then when this device was energized, the insulation failed catastrophically.For final inspection requirements, all devices are 100% inspected for damages and imperfections.It is not likely that the device left microline inc in this condition.The damages and failure to the insulation, could have only been due to age or physical damage during normal use and reprocessing, but generally damages of this extent are not seen from just an insulation breakdown of a typical device.
Event or Problem Description
There was a burning lesion to the stomach as a result of a defect in the insulation from the shaft of the laparoscopic instrument.Anesthesia time was extended for 15 minutes.No follow-up medical treatment was required.

• Brand Name: RENEW RIGID SHAFT HANDPIECE, 42CM, REUSABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8202329
• Report Number: 1223422-2018-00036
• Device Sequence Number: 18898115
• Product Code: GEI
• UDI-Device Identifier: 00811099010616
• UDI-Public: 00811099010616
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• 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
• Report Date (Section B): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3925
• Device Catalogue Number: 3925
• Device Lot Number: 00135441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/28/2018
• 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