MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN ENDO SHEARS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN ENDO SHEARS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Death (1802); No Code Available (3191)

Event Date 05/30/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Title: surgical outcomes according to the type of monopolar electrocautery device used in laparoscopic surgery for right colon cancer: a comparison of endo-hook versus endo-shears date: received: 23 january 2019 / accepted: 18 may 2019 source: jeehye lee1 · jung rae cho1 · min hyun kim1 · heung-kwon oh1 · duck-woo kim1 · sung-bum kang1 if information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to the literature source of study performed between march 2009 and march 2017, a total of 358 patients underwent monopolar endo-hook and endo-shears during laparoscopic right hemicolectomy for right colon cancer.One patient in the endo-shears group experienced anastomotic leakage, which resulted in death.

• Brand Name: UNKNOWN ENDO SHEARS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 9435008
• MDR Text Key: 169785078
• Report Number: 2647580-2019-05960
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO SHEARS
• Device Catalogue Number: UNKNOWN ENDO SHEARS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/07/2019
• 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): Death
• Patient Age: 65 YR