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

Model Number	S699GX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
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 excision of skin lesion on the patient's forehead, there were 2 repeated suture breakages.On the second occurrence, the needle could no longer be located.The patient was sent for an x-ray with a marker placed in order to locate the needle.Patient was then returned to the procedure room for the removal of the needle.There was serious patient injury.

• Brand Name: SURGIPRO
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7299636
• Report Number: 1219930-2018-01099
• Device Sequence Number: 19305446
• Product Code: GCJ
• UDI-Device Identifier: 20612479214532
• UDI-Public: (01)20612479214532
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S699GX
• Device Catalogue Number: S699GX
• Device Lot Number: D7E0086X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention