MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON CURVED INTRALUMINAL STAPLER; STAPLER, SURGICAL

Model Number ECS33A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure to Anastomose (1028)

Event Date 07/30/2019

Event Type  Injury  

Event Description

Pt scheduled for sigmoid resection with anastomosis.During surgery, colon tissue was found to be very viable with good outlook for successful surgery.Upon using stapler device, it was noted after removal that only half of the staples dislodged, thus created a significant leak.Add'l testing showed unsuccessful procedure.Surgeon opted for colostomy due to location in the colon.Pt was in surgery for 6 add'l hours.Fda safety report id# (b)(4).

• Brand Name: ETHICON CURVED INTRALUMINAL STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 8869394
• MDR Text Key: 153839672
• Report Number: MW5088864
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: ECS33A
• Device Lot Number: L92W74
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 83 YR
• Patient Weight: 106