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

Model Number UNKNOWN LAPRO-CLIP INSTRUMENT

Device Problem Misfire (2532)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Title absorbable clips have a low misfire rate and are safe for hemostasis and lymphostasis during robotic radical prostatectomy source the journal of urology, volume 189, 2013(351) date of publication: 06 may 2013.

Event Description

According to the literature, (year 2013 of may) this study aimed to evaluate the absorbable clips having a low misfire rate and are safe for hemostasis and lymphostasis during robotic radical prostatectomy procedure, sixty consecutive patients that undergo with the procedure was reported six (6) misfired occurred over the uses of 1120 clips for a misfire rate of 0.54%.Three (3) occurred during application of clips with a large amount of torque, and the other three (3) occurred in which two layers of the clip appeared to separate during application resulting in a malformed clip that provided no compression, no cases of clinically significant lymphocele, clip migration, or clip erosion occurred with short-term follow-up.

• 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: 9368590
• MDR Text Key: 167777829
• Report Number: 1219930-2019-06529
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LAPRO-CLIP INSTRUMENT
• Device Catalogue Number: UNKNOWN LAPRO-CLIP INSTRUMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1