MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC 1 PROXIMATE STAPLER; STAPLER, SURGICAL

Model Number REF: TLC75

Device Problem Failure to Fire (2610)

Patient Problem Rectal Anastomotic Leakage (4482)

Event Date 02/04/2021

Event Type  Injury  

Event Description

Once closed, stapler wouldn't fire, resulting in damaged bowel and need for further colon resection (damaged the anastomosis site).Fda safety report id # (b)(4).

• Brand Name: 1 PROXIMATE STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 11307351
• MDR Text Key: 231583209
• Report Number: MW5099318
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF: TLC75
• Device Lot Number: U40T8K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR