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

Model Number 176647

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

Patient Problem Tissue Breakdown (2681)

Event Date 08/05/2023

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products:unknown ligasur, unknown ligasure instrument (lot#unknown) reference: hiroharu kobayashi , misa kobayashi, yoshihiro takaki, 2023.Ureter injury in laparoscopic para-aortic lymphadenectomy for endometrial cancer by the transperitoneal approach.Hindawi, case reports in obstetrics and gynecology., volume 2023, article id 3138683, 6 pages, https://doi.Org/10.1155/2023/3138683 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study, laparoscopic simple hysterectomy, bilateral adnexectomy, pelvic lymph node dissection, para -aortic lymph node dissection, and partial omentectomy were performed using the transperitoneal approach (tpa). a laparoscopic fan retractor was used to lift the intestinal tracts and expand the field of view.Postoperatively, the video was reviewed and found that the retractor device bit and crumbled the fat around the left kidney, and showed that the left ureter was damaged.The ureter was trapped by the fan retractor.

• Brand Name: ENDO RETRACT II
• 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: 18121951
• MDR Text Key: 328289295
• Report Number: 2647580-2023-04867
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523000856
• UDI-Public: 10884523000856
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K920068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176647
• Device Catalogue Number: 176647
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/13/2023
• 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