MAUDE Adverse Event Report: JOHNSON AND JOHNSON APPLIER ETHICON ENDO 5MM CLIP

Model Number 253402

Device Problem Failure to Fire (2610)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/05/2016

Event Type  Injury  

Event Description

Ethicon 5mm clip applier did not load or fire properly.Neurosurgeon was attempting to clip a vessel when the clip applier did not fire.Another 5mm clip applier was immediately opened and the bleeder was controlled.

• Brand Name: APPLIER ETHICON ENDO 5MM CLIP
• Type of Device: APPLIER ETHICON ENDO 5MM CLIP
• Manufacturer (Section D): JOHNSON AND JOHNSON; 1 johnson and johnson plaza; new brunswick NJ 08933
• MDR Report Key: 6202185
• MDR Text Key: 63304678
• Report Number: MW5066891
• Device Sequence Number: 1
• Product Code: GAG
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 253402
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• 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: 80 YR
• Patient Weight: 69