MAUDE Adverse Event Report: US SURGICAL PUERTO RICO; PLATE, BASE, SHELLAC

Model Number TRIEEA28MT

Device Problems Fluid/Blood Leak (1250); Failure to Form Staple (2579)

Patient Problems Failure to Anastomose (1028); Tissue Damage (2104); No Code Available (3191)

Event Date 03/11/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the patient underwent an laparoscopic sigmoidectomy procedure.The circular stapler was used during the last step of the surgery to create the anastomosis between the distal colon and rectum stump.There was poor staple formation.The handle was fully squeezed, there was no excessive tissue incorporated in the barrel, the instrument was not improperly matched, and the donuts were complete.The anvil could be tilted after firing, the anvil was not bent, and the stapler sizers were used.A leak test was performed using a coloscope and inter-operatively the staple line looked nice.An anastomotic leak occurred three days post operatively and required re-intervention.There was temporary injury as the leak needed to be fixed.There was tissue damage as the leak was over sewn.The event lead to or extended the patients hospitalization time by two days.There was no reported patient injury.

• Type of Device: PLATE, BASE, SHELLAC
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7441385
• MDR Text Key: 105875090
• Report Number: 2647580-2018-01909
• Device Sequence Number: 1
• Product Code: EEA
• UDI-Device Identifier: 20884521593029
• UDI-Public: 20884521593029
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: TRIEEA28MT
• Device Catalogue Number: TRIEEA28MT
• Device Lot Number: V7M0963X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention