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

Lot Number T93D58

Device Problem Misfire (2532)

Patient Problem Laceration(s) (1946)

Event Date 07/12/2019

Event Type  Injury  

Event Description

Endoscopic multiple clip applier misfired during a laparoscopic cholecystectomy cause a small laceration in the cystic duct.A new clip applier had to be retrieved to complete the procedure.The surgeon felt that is the applier would have transected the duct completely it would have been a complication.The cystic duct had to be transected in order to remove the gallbladder as part of the normal process of the procedure.Fda safety report id # (b)(4).

• Brand Name: ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; blue ash OH 45242
• MDR Report Key: 8794096
• MDR Text Key: 151337533
• Report Number: MW5088162
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/12/2019

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 Expiration Date: 04/30/2024
• Device Lot Number: T93D58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• 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: 64 YR
• Patient Weight: 82