MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SILS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SILSHOOK36
Medical Device Problem Codes	Device Remains Activated (1525); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
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 a video-assisted thoracoscopic surgery lobectomy, while approaching the lung, the trigger of the device became stuck and the device would not stop activating the energy.Surgeon had to physically push the trigger open to stop the energy activation.They used another device to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Engineering found that activation worked as intended and tactile feedback was present on both buttons.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a video-assisted thoracoscopic surgery lobectomy, while approaching the lung, the trigger of the device became stuck and the device would not stop activating the energy.Surgeon had to physically push the trigger open to stop the energy activation.They used another device to complete the case.No patient injury.

• Brand Name: SILS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8084577
• Report Number: 1219930-2018-06169
• Device Sequence Number: 19414631
• Product Code: GCJ
• UDI-Device Identifier: 10884523000627
• UDI-Public: 10884523000627
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 05/31/2023
• Device Model Number: SILSHOOK36
• Device Catalogue Number: SILSHOOK36
• Device Lot Number: N8E1086X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1