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

Model Number MCL20

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 03/09/2022

Event Type  Death  

Event Description

Critically ill patient underwent a nephrectomy and had to return to surgery for bleeding where it was discovered the hemorrhage was from the right adrenal gland with a clip failure.Additional clips remained partially occluding the renal vein, but not enough to stop blood flow.There was a small defect approximately 1 mm in the vena cava directly posterior to the vein, where the surgeon suspects the tip of the clip had pinched the vena cava when it was placed or when it failed, it made a small hole.Patient underwent a massive transfusion but ultimately was unable to recover from his surgery.Fda safety report id# (b)(4).

• Brand Name: ETHICON LIGACLIP APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC.
• MDR Report Key: 14843551
• MDR Text Key: 294922270
• Report Number: MW5110542
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/24/2022

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: 02/02/2022
• Device Model Number: MCL20
• Device Catalogue Number: MCL20
• Device Lot Number: 175A96
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White