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

Model Number MCS20

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

The ligaclip was not working properly per surgeon.It was not deploying clip as if it was empty.A new product was opened to complete the procedure.

• Brand Name: LIGACLIP
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11817717
• MDR Text Key: 250417809
• Report Number: 11817717
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCS20
• Device Catalogue Number: MCS20
• Device Lot Number: U40N57
• 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: 05/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA