MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Codes	Positioning Problem (3009); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the system would not expose.The system initially worked during the case but later after taking four spins, it stopped working.The user tried to dock the system but it would not respond.The user said that the system needed to be docked to leave the operating room.The system was then stuck in the operating room.Medtronic imaging was aborted.There was no impact on patient outcome.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id bi71000424 (lot: -); product type: 3032-ias panel (o2) electrical comp brand name ; product id bi71000167 (lot: -); product type: 2560-mnav - o-arm system brand name ; product id bi71000529 (lot: -); product type: 2560-mnav - o-arm system brand name ; product id bi71000529 (lot: -); product type: 2560-mnav - o-arm system h3: the system was serviced in the field and the rear cab and the umbilical were replaced.The field service engineer (fse) performed system check out and performed multiple 2-d and 3-d images.Multiple system restarts were performed, and the system was operating properly and had not failed.Codes b01, c07, d02 are applicable to this analysis.H6: multiple annex g codes were reported.G04096 corresponds to concomitant product bi71000424 that comprises the reported event.G04018 corresponds to concomitant product bi71000167 that comprises the reported event.G02040 corresponds to concomitant product bi71000529 that comprises the reported event.Multiple fdd/annex a codes were reported.A090501 was coded for the system being unable to expose.A1502 was coded for the system not docking.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
An additional evaluation of the system was performed by a manufacturer representative who went to the site to test the imaging system.The pendant was replaced.The back cover and right sidewall of ias generator were realigned.The cabling in generator sections were rerouted.A system checkout was performed and the imaging system was operational.Previously reported codes b01, c07, and d02 are applicable.Evaluation of the returned bi71000424 panel rearcab brkt lot#: 916 rev.D found that the rearcab brkt failed the bench test.The continuity test failed.The key forb failed.The normally closed contacts were open.Codes c02 and previously reported b01, d02 apply.Evaluation of the returned bi71000167 cblasy dbl shldmvs lot#: 908 rev.D found that the umbilical cable passed bench test.The continuity test passed.A visual inspection confirmed a cracked cat6 molding and missing harting cover and locking lever.The cable was installed in an imaging system and the system did not initialize.There were intermittent issues.Codes c02 and previously reported b01, d02 apply.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.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20514253
• Report Number: 3004785967-2024-00622
• Device Sequence Number: 18296843
• Product Code: OWB
• UDI-Device Identifier: 00763000068066
• UDI-Public: 00763000068066
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 73 KG