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

Model Number	178099
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre-operatively, the tip of the device was burned.The black sheath cover loose from the shaft and the distal tip of the black sheath was damaged.There was no patient involvement.
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 tip of the device was burned during activating monopolar function.The black sheath cover loose from the shaft and the distal tip of the black sheath was damaged.There was no patient involvement.

• 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: 7203364
• Report Number: 2647580-2018-00349
• Device Sequence Number: 1133592
• Product Code: GEI
• UDI-Device Identifier: 20884523000938
• UDI-Public: 20884523000938
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K961771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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: 01/31/2022
• Device Model Number: 178099
• Device Catalogue Number: 178099
• Device Lot Number: P7A0475X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1