MAUDE Adverse Event Report: COVIDIEN ENDO CLIP II; CLIP, IMPLANTABLE

Model Number 176657

Device Problem Misfire (2532)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

During surgery for the removal of a gallbladder, a covidien clip applier misfired and did not continue to function properly.Per communication from the surgical technologist involved in the case, the clip applier instead of clipping actually cut the artery.The surgeon requested a new clip applier and held the bleeder with a grasper until the new clip applier was opened.The second clip applier functioned properly, and the surgeon was able to easily control the bleeding.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 15804676
• MDR Text Key: 303722661
• Report Number: 15804676
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2022,10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J2E1840NY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2022
• Date Report to Manufacturer: 11/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27010 DA
• Patient Sex: Female