MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW ENDOCUT SCISSORS TIP DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3142
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual inspection, this complaint has been confirmed.The returned tip was returned with a defective heat shrink.During investigation the tip was evaluated under 20x magnification.Evaluation of the front hub indicate that an unintended energization may have occur at that location.A small burn was noted on the center of the heat shrink.No other defects were noted on the device.The insulation of the heat shrink may have been compromised if the heat shrink came in contact with another device.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.This complaint is confirmed.The root cause cannot be determined because of the condition of the returned device.
Event or Problem Description
During the release of the gallbladder with the laparoscopic scissors, a spark appeared at the disposable tip, which burned the duodenum.The procedure and anesthesia time were extended for an unknown amount of time.

• Brand Name: RENEW ENDOCUT SCISSORS TIP DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7695753
• Report Number: 1223422-2018-00020
• Device Sequence Number: 13841568
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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 Expiration Date: 12/28/2022
• Device Model Number: 3142
• Device Catalogue Number: 3142
• Device Lot Number: 00138719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/17/2018
• 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