MAUDE Adverse Event Report: US SURGICAL PUERTO RICO SURGIWAND II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	178094
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Codes	Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic cholecystectomy procedure, the current reached not only the tip of the device but also proximal side (hand side) of the device.It influenced more tissue than usual.The procedure was completed with another device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The distal end of the sleeve was observed to be melted and charred at some points.The tip of the device was observed to be burnt.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Replication of the reported condition may occur when the tip of the device contacts conductive irrigation fluid or other conductive material such as metal, causing a large discharge of energy.The instructions for use (ifu) for the device clearly states in numbers six and seven respectively: ¿when using electrocautery, ensure that the outer sleeve is fully retracted to expose the tip of the device, as failure to do so may compromise discharge of energy from the electrode.¿ and ¿when using electrocautery, ensure that the electrode is not in contact with conductive irrigation fluid, as this may compromise discharge of energy from the electrode.¿ replication of heat damage to the sleeve may occur when the tip makes contact with the sheath of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic cholecystectomy procedure, the current reached not only the tip of the device but also proximal side (hand side) of the device.It influenced more tissue than usual.The incident was reported that it may cause burn.The procedure was completed with another device.There was no patient injury.

• Brand Name: SURGIWAND II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7686342
• Report Number: 2647580-2018-03496
• Device Sequence Number: 10988969
• Product Code: GEI
• UDI-Device Identifier: 10884523000917
• UDI-Public: 10884523000917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2018

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: 03/31/2023
• Device Model Number: 178094
• Device Catalogue Number: 178094
• Device Lot Number: P8C1114X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/14/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1