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U.S. Department of Health and Human Services

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

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CAREFUSION 2200, INC V. MUELLER; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES Back to Search Results
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.
 
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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 Key9151601
MDR Text Key161102685
Report Number9151601
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Number of Events Reported1
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 NumberLA8203
Device Catalogue NumberLA8203
Device Lot Number0744654
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/01/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2019
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer10/03/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/03/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age24455 DA
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