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

Model Number	178093
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the sleeve of the instrument was damaged.It was reported that the device showed signs of melting.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the sleeve of the device is not fully retracted during use or and the tip of the device contacts conductive irrigation fluid or other conductive material such as metal.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: 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.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic cholecystectomy, when the surgeon activated the coagulant energy to coagulate the gallbladder, the tip of the black sheath was melted.A reusable instrument was used to complete the case.There was no patient injury.

• Brand Name: SURGIWAND II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 12459050
• Report Number: 2647580-2021-03093
• Device Sequence Number: 4067728
• Product Code: GEI
• UDI-Device Identifier: 10884523000900
• UDI-Public: 10884523000900
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K961771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 02/28/2026
• Device Model Number: 178093
• Device Catalogue Number: 178093
• Device Lot Number: P1C0905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1