MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON ENDO-SURGERY 75MM LINEAR CUTTER; STAPLER, SURGICAL

Model Number REF TLC75

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Event Description

Dr.(b)(6) was performing proctectomy with ileoanal anastomosis when the stapler misfired.No harm to the patient.

• Brand Name: ETHICON ENDO-SURGERY 75MM LINEAR CUTTER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; cincinnati OH 45242
• MDR Report Key: 8428596
• MDR Text Key: 139219867
• Report Number: MW5084983
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: REF TLC75
• Device Lot Number: R40X6P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 40 YR