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U.S. Department of Health and Human Services

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

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US SURGICAL PUERTO RICO PLATE, BASE, SHELLAC Back to Search Results
Model Number TRIEEA28MT
Device Problems Fluid 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.
 
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Type of DevicePLATE, 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 Key7441385
MDR Text Key105875090
Report Number2647580-2018-01909
Device Sequence Number1
Product Code EEA
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRIEEA28MT
Device Catalogue NumberTRIEEA28MT
Device Lot NumberV7M0963X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/18/2018 Patient Sequence Number: 1
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