MAUDE Adverse Event Report: COVIDIEN LP PREMIUM SURGICLIP III; CLIP, IMPLANTABLE

Model Number 133650

Device Problem Misfire (2532)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

During the procedure, the clip applier misfired and caused the vessels to bleed.

• Brand Name: PREMIUM SURGICLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; 02048 MA
• MDR Report Key: 10777949
• MDR Text Key: 214335433
• Report Number: 10777949
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Device Lot Number: 1366Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA
• Patient Weight: 47