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

Model Number	GL-323
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
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, during a caesarean section lipoma removal procedure, and while the suture was being used for tissue closure, the tip of suture needle broke off and fell into the patient's cavity.The needle tip was recovered and the case was completed.There was a mark left on the skin from the pencil.A temporary injury was reported.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted one partial suture and one needle.The needle was received with the needle tip broken.The needle was observed to be attached to the partial suture.Upon microscopic inspection of the needle, instrument marks were observed at the needle tip of the needle.No sealed samples were received.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.The observed instrumentation damages suggested that the needles were grasped improperly at the needle tip during application.Firmly grasping the needle at the tip weakens the needle causing it to bend and/or break.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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.
Event or Problem Description
According to the reporter, during a caesarean section lipoma removal procedure, and while the suture was being used for tissue closure, the tip of suture needle broke off and fell into the patient's cavity.The needle tip was recovered and the case was completed.There was a mark left on the skin from the pencil.New suture was used to complete the procedure.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7454361
• Report Number: 1219930-2018-02222
• Device Sequence Number: 19175695
• Product Code: GAM
• UDI-Device Identifier: 10884521045255
• UDI-Public: 10884521045255
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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: 11/30/2022
• Device Model Number: GL-323
• Device Catalogue Number: GL-323
• Device Lot Number: A7L0979X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR