MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCL1544
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Sepsis (2067); Peritonitis (2252); Injury (2348); No Code Available (3191)
Date of Event	08/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual evaluation of both the videos and received samples found no abnormalities which would indicate any manufacturing issue which may have contributed to this failure.Evidence of material transfer as a result of the welding process was found on each specimen; however, it is not possible to verify the tensile load that was applied to the opened suture received which caused it to break.Additionally, a review of the video evidence provided found that the suture was not applied in accordance with the ifu, as the surgeon took several extra bites before applying tension to appose the tissue and anchor the loop.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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 will be amended as appropriate.
Event or Problem Description
According to the reporter: occurred post-operatively after a laparoscopic gastric bypass.The surgeon employed a running stitch using barbed suture.The suture was removed approximately 10-15 minutes prior to use.The patient was re-admitted to the er due to leakage.There was a hole in the jejunum at the closing of the enterotomy.The patient developed peritonitis and sepsis.To correct the issue, an additional operation was performed to close the hole in the jejunum and clean the bowels.This extended patient hospitalization.The patient had to be resuscitated in the icu.Current patient status is stable.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6901799
• Report Number: 1219930-2017-07520
• Device Sequence Number: 19128151
• Product Code: GAM
• UDI-Device Identifier: 20884521131467
• UDI-Public: 20884521131467
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: VLOCL1544
• Device Catalogue Number: VLOCL1544
• Device Lot Number: A7D0499VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention