MAUDE Adverse Event Report: ETHICON ENDO-SURGERY ETHICON LIGACLIP APPLIER; APPLIER, SURGICAL, CLIP

Model Number MCC20

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

Surgeon attempted apply 4th clip and the device failed.

• Brand Name: ETHICON LIGACLIP APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 12445849
• MDR Text Key: 270561145
• Report Number: 12445849
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2021,08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCC20
• Device Catalogue Number: MCC20
• Device Lot Number: 175A96
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2021
• Date Report to Manufacturer: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1