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

Model Number UNKNOWN VLOC PRODUCT

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, 3 weeks post-operative of a robotic bilateral inguinal hernia where each side was closed with a suture using a running stitch technique, only one side healed as expected.The whole suture on the other side appeared spit into cavity.The device migrated from the peritoneum and attached to bowel which caused an obstruction.The suture was removed to resolve the issue.

• Brand Name: UNKNOWN VLOC PRODUCT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10271429
• MDR Text Key: 198732440
• Report Number: 1219930-2020-02796
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN VLOC PRODUCT
• Device Catalogue Number: UNKNOWN VLOC PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention