MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON SILS CLINCH 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SILSCLINCH36
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Codes	Burn(s) (1757); Tissue Damage (2104)
Date of Event	07/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference number: (b)(4).
Event or Problem Description
According to the reporter, during the sils appendectomy, the device grounded on the pre-umbilical skin and caused a small burn at the site where they all touch.The sils device insulation was not durable enough to support other instruments rubbing against it at the single insertion access point.There was no medical intervention done to the patient.A wound dressing (gauze) was placed on the patient but that was per normal procedure.There was minor tissue damage due to the burn.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering evaluation, and an evaluation of the returned device.The rotation knob functioned without difficulty.The jaws opened and closed without difficulty, and grasped test media.The ratchet mechanism functioned properly.The lock engaged and functioned properly.Visual inspection noted damage to the shaft.The observed damaged did not affect the functionality of the device.Replication of the observed condition may occur if a sharp edged object scrapes along the shaft.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: SILS CLINCH 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5952405
• Report Number: 1219930-2016-00982
• Device Sequence Number: 18923230
• Product Code: GCJ
• UDI-Device Identifier: 10884523000580
• UDI-Public: (01)10884523000580(17)210131(10)N6A0333X
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K091869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2016

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: 01/31/2021
• Device Model Number: SILSCLINCH36
• Device Catalogue Number: SILSCLINCH36
• Device Lot Number: N6A0333X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/24/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 10/13/2016; 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 72