MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-129
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
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, intra-operatively, a ¿surjet¿ suturing technique was employed by the surgeon, but at the end of the open procedure, the first and second suture had thread broken but the other one had needle separated from the thread and fell into the patient cavity and was retrieved by the surgeon.The first doctor took another suture but the needle quickly twisted and then the second doctor took another suture and it worked.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of two devices.One needle was returned disengaged from the suture.Upon microscopic inspection, proper crimp marks were noted at the swaged end.The visual inspection and functional evaluation of the sealed sample had acceptable results.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7436749
• Report Number: 1219930-2018-02059
• Device Sequence Number: 1678051
• Product Code: GAM
• UDI-Device Identifier: 10884521045033
• UDI-Public: 10884521045033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 09/01/2019
• Device Model Number: GL-129
• Device Catalogue Number: GL-129
• Device Lot Number: A4J1176X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/08/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 07/16/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1