MAUDE Adverse Event Report: COVIDIEN LP ENDOCLIP II 10MM CLIP APPLIER; CLIP, IMPLANTABLE

Model Number 176657

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2021

Event Type  malfunction  

Event Description

During a laparoscopic appendectomy.An endo gia ultra universal stapler was used a few times without issue then it misfired.

• Brand Name: ENDOCLIP II 10MM CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11655282
• MDR Text Key: 245094484
• Report Number: 11655282
• 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: 04/06/2021

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: No Information
• Device Model Number: 176657
• Device Catalogue Number: 176657
• 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: 04/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Weight: 62