MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGITIE; SUTURE, ABSORBABLE, NATURAL

Model Number	ED-20-L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the device's thread was broken.No patient involved.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two images and one device.The visual inspection and functional evaluation of the sample had acceptable results.The images noted the packaging in an undamaged condition, as well as the product placed in the package crooked.Dimensional, visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported condition and the reported condition was not confirmed.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 amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGITIE
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6794806
• Report Number: 1219930-2017-06421
• Device Sequence Number: 131673
• Product Code: GAL
• UDI-Device Identifier: 10884521099661
• UDI-Public: 10884521099661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K904588
• 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): 02/06/2018

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: 03/31/2019
• Device Model Number: ED-20-L
• Device Catalogue Number: ED-20-L
• Device Lot Number: N4C0745X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1