MAUDE Adverse Event Report: ETHICON ENDO SURGERY, LLC LIGAMAX5 ENDOSCOPIC MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Model Number U93G2P

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Event Description

Endoscopic multiple clip applier misfired per surgeon.No harm to patient.Fda safety report id# (b)(4).

• Brand Name: LIGAMAX5 ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 10074402
• MDR Text Key: 191609386
• Report Number: MW5094548
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2020

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: U93G2P
• Device Catalogue Number: EL5ML
• Device Lot Number: U93G2P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2020
• 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 Age: 67 YR
• Patient Weight: 80