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

Model Number	178099
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2018
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, pre-operatively, the device shaft was burnt down about 3cm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The distal end of the sleeve was observed to be melted and charred.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.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 the reported condition may occur when the tip makes contact with the sheath of the device.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 8088865
• Report Number: 2647580-2018-05640
• Device Sequence Number: 19207870
• Product Code: GEI
• UDI-Device Identifier: 10884523000931
• UDI-Public: 10884523000931
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K961771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 06/30/2023
• Device Model Number: 178099
• Device Catalogue Number: 178099
• Device Lot Number: P8F1627X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/28/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1