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

Model Number	178081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
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, during totally laparoscopic distal gastrectomy, the device¿s suction button was broken.New device was used to complete the case.No reported patient outcome.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.During testing and examination at ponce it was determined that there was no evidence of any malfunction of the device.The suction button was pressed several times and the function and return time of the button was found to be acceptable.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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7402638
• Report Number: 2647580-2018-01717
• Device Sequence Number: 16693306
• Product Code: GEI
• UDI-Device Identifier: 20884523000860
• UDI-Public: 20884523000860
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 05/31/2022
• Device Model Number: 178081
• Device Catalogue Number: 178081
• Device Lot Number: P7E0719X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 06/29/2018; 08/08/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/19/2018; 07/16/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1