MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON-LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  Injury  

Event Description

During a lap chole surgery, there was an issue with a ligaclip, trigger got stuck, unable to open.Fda safety report id# (b)(4).

• Brand Name: ETHICON-LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; cincinnati OH 45242 2879
• MDR Report Key: 9233955
• MDR Text Key: 163934421
• Report Number: MW5090616
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER320
• Device Lot Number: T40P63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR