MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MINI STEP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	MS100705
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	11/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitant products: ms100703, ms100703 mini step 2/3 short st x10 (lot#p2e0305); ms100703, ms100703 mini step 2/3 short st x10 (lot#p2e0305); ms100705, ms100705 short mini 5mm s/c/d st x10 (lot#p4g1261).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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a lobectomy procedure, a laparoscopic approach was converted to open surgery due to a problem with the four trocar devices, specifically the fraying of the trocars' shirt.This conversion resulted in a larger than expected incision, leading to permanent tissue damage and a 10 centimeter (cm) scar.The surgical time was extended by 30 minutes or more, increasing the risk of infection due to prolonged anesthesia and open surgery.The incision was extended by more than 1 inch (2.54 cm).Unanticipated tissue loss was noted.
Additional Manufacturer Narrative
Correction: h6 (e2014 added).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.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (fdd) 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 or Problem Description
It was reported that during a lobectomy procedure, a laparoscopic approach was converted to open surgery due to a problem with the four trocar devices, specifically the fraying of the trocars' transparent mesh.This conversion resulted in a larger than expected incision, leading to permanent tissue damage and a 10 centimeter (cm) scar.The surgical time was extended by 30 minutes or more, increasing the risk of infection due to prolonged anesthesia and open surgery.The incision was extended by more than 1 inch (2.54 cm).Unanticipated tissue loss was noted.

• Brand Name: MINI STEP
• Common Device Name: 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: 21072071
• Report Number: 2647580-2024-05203
• Device Sequence Number: 19685566
• Product Code: GCJ
• UDI-Device Identifier: 20884521082707
• UDI-Public: 20884521082707
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K961430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: MS100705
• Device Catalogue Number: MS100705
• Device Lot Number: P4G1261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 01/15/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/06/2025; 01/16/2025
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 MO
• Patient Sex: Female
• Patient Weight: 11 KG