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

Model Number UNKNOWN HERNIA STAPLER

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

Patient Problems Hernia (2240); Unintended Radiation Exposure (4565)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Reference: s.D.Kristensen, bjs, 2021, randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery, 108, 145¿151 doi: 10.1093/bjs/znaa055.Accepted: september 28, 2020.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the literature source of study performed between 13th august 2012 and 18th may 2017, a randomized trial evaluated the benefit and harm of closing mesenteric defects with clips during laparoscopic bypass surgery between august 2012 and may 2017.It was noted that the mesenteric defects were closed with either a hernia stapler or a competitor product.There were 401 patients, included in the study, 200 had non closure defects and 201 had closure defects.Complications included internal herniation treated with re-operation.Internal herniation was defined as herniation of the small bowel through one or both of the mesenteric defects as diagnosed by ct scan and/or laparoscopy, and requiring surgical correction and closure of the mesenteric defect.

• Brand Name: UNKNOWN HERNIA STAPLER
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19022896
• MDR Text Key: 339152969
• Report Number: 2647580-2024-01460
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN HERNIA STAPLER
• Device Catalogue Number: UNKNOWN HERNIA STAPLER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• 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): Required Intervention; Other