MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENSEAL TEMP CONTROLLED TISSUE SEALING TECH

Model Number	10NSEAL545RH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the enseal 45cm stopped working.It was immediately replaced and there was no harm to the pt.

• Brand Name: ENSEAL TEMP CONTROLLED TISSUE SEALING TECH
• Common Device Name: ENSEAL TEMP CONTROLLED TISSUE SEALING TECH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; cincinnati OH 45242 2839
• MDR Report Key: 6724624
• Report Number: MW5071082
• Device Sequence Number: 947376
• Product Code: GEI
• UDI-Device Identifier: 10705036000051
• UDI-Public: (01)10705036000051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 10NSEAL545RH
• Device Lot Number: P91G2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66