MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON V-LOC 180 ABS CLOS DEVICE 3-0 CL 24 P-14; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number VLOCL0134

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested but not yet received.A supplemental will be submitted upon receipt of any new information.

Event Description

According to the reporter: the surgeon had a one year check up with a bariatric patient who he had performed a laparoscopic gastric bypass procedure on.The suture was used during the procedure, but the patient had the suture obstructing the small bowel.It had migrated from the original mesenteric defect, which the suture was used to close, to the small bowel and partially obstructed it.

• Brand Name: V-LOC 180 ABS CLOS DEVICE 3-0 CL 24 P-14
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6249064
• MDR Text Key: 64760280
• Report Number: 1219930-2017-00051
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLOCL0134
• Device Catalogue Number: VLOCL0134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other