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

Model Number	178081
Medical Device Problem Codes	Break (1069); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
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 a procedure, the first device broke shortly after starting to use it.The second one's issue was that total suction did not work.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that one of the devices was returned with the suction button separated from the device.The suction button had a deformed flange.Scratches were observed around the suction button assembly.Functional testing was not performed based on the condition the device was received in.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 a disengaged suction or irrigation button may occur if the user excessively manipulates the button and\or exerts angular pressure on the button which results in damage to the button assembly.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy procedure, the first device broke shortly after starting to use it.The second one's issue was that total suction did not work.Another device was used to complete the case.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: 9742239
• Report Number: 2647580-2020-00668
• Device Sequence Number: 2475108
• Product Code: GEI
• UDI-Device Identifier: 10884523000863
• UDI-Public: 10884523000863
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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 Model Number: 178081
• Device Catalogue Number: 178081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1