MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS LIGHTED RESTRACTOR SOLSTICE B1; RETRACTOR

Model Number	50-101-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received.It was reported that the debris was found only in the handpiece packaging which was never opened, no damage to the instrument reported.
Additional Manufacturer Narrative
B5 updated with new information received.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
(h3,h6): no parts have been received by the manufacturer for evaluation.Codes b17, c20 <(>&<)> d15 are applicable.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
Information was received from a medtronic representative on behalf of healthcare provider regarding a generator and a handpiece.It was reported that the handpiece was damaged and sterile packaging of handpiece was observed to have debris inside.There was no patient involved.

• Brand Name: LIGHTED RESTRACTOR SOLSTICE B1
• Common Device Name: RETRACTOR
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis,mn
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis,mn
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24845024
• Report Number: 2182208-2026-18712
• Device Sequence Number: 8947031
• Product Code: GAD
• UDI-Device Identifier: 00763000432799
• UDI-Public: (01)00763000432799(17)280930(10)A293(20)01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: 50-101-1
• Device Catalogue Number: 50-101-1
• Device Lot Number: A293
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• 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
• Patient Sex: Unknown