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

Catalog Number NSLG2C35

Device Problems Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

Enseal curved 5x35 device used for laparoscopic surgical procedure.Mid-use, the device was no longer functioning properly; device appeared intact, one jaw portion appeared to be curved differently than the other jaw piece and was not working as strongly as earlier during procedure.

• Brand Name: ENSEAL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 9535068
• MDR Text Key: 173210310
• Report Number: 9535068
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2019

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 Catalogue Number: NSLG2C35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 103