MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LA8203

Device Problems Break (1069); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/13/2019

Event Type  malfunction  

Event Description

During the laparoscopic portion of the surgery, the blunt locking grasper instrument broke.A small piece (approximately 0.5cm square) of black plastic near the tip of the instrument broke off the shaft while inside the patient's abdomen.The piece was seen in the abdomen but upon switching out instruments to retrieve the piece, it disappeared from view.The piece was not retrievable after search of the abdominal cavity.Another sterile instrument replaced the broken one and the surgery continued as planned.Manufacturer response for blunt locking grasper, integra jarit (per site reporter) i'm uncertain of the date, the plan was to send it back to be repaired.

Event Description

During the laparoscopic portion of the surgery, the blunt locking grasper instrument broke.A small piece (approximately 0.5cm square) of black plastic near the tip of the instrument broke off the shaft while inside the patient's abdomen.The piece was seen in the abdomen but upon switching out instruments to retrieve the piece, it disappeared from view.The piece was not retrievable after search of the abdominal cavity.Another sterile instrument replaced the broken one and the surgery continued as planned.Manufacturer response for blunt locking grasper, integra jarit (per site reporter).I'm uncertain of the date, the plan was to send it back to be repaired.

• Brand Name: V. MUELLER
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CAREFUSION 2200, INC; 589 davies drive; york PA 17402
• MDR Report Key: 9151601
• MDR Text Key: 161102685
• Report Number: 9151601
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/12/2019,09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LA8203
• Device Catalogue Number: LA8203
• Device Lot Number: 0744654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24455 DA