MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM0114
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a hysterectomy procedure, at the start of wound closure, both the needle and the thread broke.The loop where the needle is attached to the thread came loose when the surgeon wanted to use it.A new device was used to complete the case.There was no patient injury.
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 hysterectomy procedure, at the start of wound closure, both the needle and the thread broke.The first suture broke from the needle.And on the second suture, he loop where the needle is attached to the thread came loose when the surgeon wanted to use it.A new device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the sample noted two sutures and two needles.One of the needles was returned disengaged from the suture.Normal crimp and swage marks were noted on the detached needle.The other suture was returned with the loop open.Upon microscopic inspection, evidence of material transfer was noted on the loop.As no sealed samples were returned, needle attachment and laced through loop tests could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 90
• 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: 7714688
• Report Number: 1219930-2018-04037
• Device Sequence Number: 16404236
• Product Code: GAM
• UDI-Device Identifier: 10884521131750
• UDI-Public: 10884521131750
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2019

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: 02/28/2021
• Device Model Number: VLOCM0114
• Device Catalogue Number: VLOCM0114
• Device Lot Number: A8B0913VFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 08/08/2018; 02/22/2019
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/14/2018; 10/03/2018; 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1