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

Model Number	178094
Medical Device Problem Codes	Break (1069); Melted (1385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic right hemicolectomy procedure, approximately an hour after the start of surgery, the tip of the black shaft broke.The distal tip of the black sheath was damaged.Due to the bending of the electrode, it seemed to be burned where it made contact with the shaft during storage.The procedure was completed with another device.The status of the patient is alive with no injury.
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 broken and burnt.The spatula tip was observed to be bent.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the reported condition may occur when the spatula tip is bent out of alignment and makes contact with the sheath of the device.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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: 6887851
• Report Number: 2647580-2017-06789
• Device Sequence Number: 16267366
• Product Code: GEI
• UDI-Device Identifier: 20884523000914
• UDI-Public: 20884523000914
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: 04/30/2022
• Device Model Number: 178094
• Device Catalogue Number: 178094
• Device Lot Number: P7D1118X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1