MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON ENDO SURGERY ENSEAL TISSUE SEALER G2DF; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number V94423

Device Problem Defective Component (2292)

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

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Jaws failed to function properly.Fda safety report id # (b)(4).

• Brand Name: ETHICON ENDO SURGERY ENSEAL TISSUE SEALER G2DF
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00696
• MDR Report Key: 12031803
• MDR Text Key: 257433754
• Report Number: MW5101961
• 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: 06/15/2021

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 Lot Number: V94423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• 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 Age: 78 YR