MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 174015

Device Problem Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic hernia procedure, while closing the peritoneum, the staples did not fully close leaving an opening for bowel to get entrapped in.The entrapped bowel was released without issue.They had to re-operate to remove trapped bowel.The event lead to an extended hospital stay for one day.

• Brand Name: MULTIFIRE ENDO HERNIA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 8297033
• MDR Text Key: 134736750
• Report Number: 2647580-2019-00622
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070554
• UDI-Public: 10884521070554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174015
• Device Catalogue Number: 174015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• 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): Hospitalization; Required Intervention