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

Model Number	SILSHOOK36
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device fell apart towards end of case.The case was able to complete with no intervention needed.There was no injury caused to the patient and no medical intervention was required.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.Visual functional indicated no abnormalities.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.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermottt rd; north haven CT 06473
• MDR Report Key: 6945888
• Report Number: 1219930-2017-07955
• Device Sequence Number: 505776
• Product Code: GCJ
• UDI-Device Identifier: 10884523000627
• UDI-Public: 10884523000627
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K091869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 05/31/2021
• Device Model Number: SILSHOOK36
• Device Catalogue Number: SILSHOOK36
• Device Lot Number: N6E0442X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1