MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON LIGACLIP 10 M/L ; APPLIER, SURGICAL, CLIP

Model Number ER 320

Device Problems Leak/Splash (1354); Contamination of Device Ingredient or Reagent (2901); Output Problem (3005); Appropriate Term/Code Not Available (3191)

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

Event Date 07/09/2018

Event Type  Injury  

Event Description

Ethicon ligaclip 10m/l "scissored" where surgeon applied it to cystic duct.Five clips misfired.New clip applier opened, and it did not work.Scissoring of clip caused bile leak.Wound class changed to contaminated, #3.Endo loop used to seal duct.

• Brand Name: ETHICON LIGACLIP 10 M/L
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; cincinnati OH
• MDR Report Key: 7713838
• MDR Text Key: 114951974
• Report Number: MW5078521
• Device Sequence Number: 1
• Product Code: GDO
• 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: 07/09/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: ER 320
• Device Lot Number: R40713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2018
• 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: 34 YR