MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. APPLIER, SURGICAL, CLIP

Model Number MSM20

Device Problems Failure to Deliver (2338); Mechanical Jam (2983)

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

Event Date 06/10/2021

Event Type  Injury  

Event Description

Clip applier was working normally, then when the next clip was going to be applied to the vessel, the clip jammed in dispenser.No clips were coming out.The clip applier and packaging saved, tagged, and given to manager.Fda safety report id# (b)(4).

• Brand Name: APPLIER, SURGICAL, CLIP
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 12016599
• MDR Text Key: 257197090
• Report Number: MW5101942
• Device Sequence Number: 1
• Product Code: GDO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSM20
• Device Lot Number: 239A89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• 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