MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN LAPRO-CLIP RELOAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Abscess (1690)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

Title: absorbable polymeric surgical clips for appendicular stump closure: a randomized control trial of laparoscopic appendectomy with lapro-clips source: oncotarget, vol.7, no.27 published: may 11, 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed april 1, 2012 and february 3, 2015, a randomized control trial was performed to evaluate the effectiveness and safety of absorbable polymeric clips for appendicular stump closure in laparoscopic appendectomy (la).A total of 1,100 patients were randomly enrolled into an experimental group (ligation of the appendicular) or control group.Overall, 99 patients developed a complication following la.Rates of intra-abdominal abscess were comparable between groups.Stump leakage occurred in 3 total patients, at comparable rates between the groups.Re-operation was required also at comparable rates between groups.

• Brand Name: LAPRO-CLIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 11744008
• MDR Text Key: 247897372
• Report Number: 1219930-2021-01674
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LAPRO-CLIP RELOAD
• Device Catalogue Number: UNKNOWN LAPRO-CLIP RELOAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• 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
• Patient Age: 37 YR