MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. LAPAROSCOPIC TISSUE SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number U94689

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  Injury  

Event Description

The valve on a patient's vp shunt was defective and had to be replaced.Fda safety report id# (b)(4).

• Brand Name: LAPAROSCOPIC TISSUE SEALER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; MX
• MDR Report Key: 10606054
• MDR Text Key: 209455760
• Report Number: MW5096962
• Device Sequence Number: 1
• Product Code: GEI
• 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: 09/28/2020

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: 05/20/2024
• Device Lot Number: U94689
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR