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

Model Number BI70002000

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Positioning Problem (3009); Noise, Audible (3273); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the gantry would not open around a patient.The manufacturer representative reported that when they arrived in the operating room to assist the staff in opening the imaging system, the wrench was in the hole with the "2" marker without the t-handle inserted into the "1" hole.The manufacturer representative said they tried to use the button on the pendant, but the image acquisition system (ias) was unresponsive.The imaging system did not take shots for the case, so imaging system usage was aborted.The site were only going to use the imaging system for screw placement confirmation, and not for navigation.The surgeon used their c-arm to continue the case.Troubleshooting included the manufacturer representative tried to use the wrench to align the hole between the "green" and the "orange" but was unable to rotate the "1" hole.Technical services (ts) could hear a clicking sound over the phone, and the manufacturer representative reported it as "slipping." the detector and source would not rotate using the wrench.The manufacturer representative attempted to rotate the detector and source in the opposite direction, but that did also not work.Ts asked the manu facturer representative to try the open gantry button again, but the ias did not respond at all.The manufacturer representative tried using the emergency button on the side of the imaging system, but that did also not generate a response from the imaging system.The imaging system logs on the mobile viewing system (mvs) had a warning, "disabling 2dlf (2d long film) feature," and an error, " error can emergency event for the board.Mvs power control monitor." the mvs also displayed more errors.This occurred intraoperatively, and there was no reported surgical delay.There was no reported impact to patient outcome.

Manufacturer Narrative

Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000273, serial/lot #: none, product id: bi71000429, serial/lot #: unknown, no parts have been returned to medtronic for analysis.B17, c20, d15 are applicable.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.

Manufacturer Narrative

Continuation of d10) additional information: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000192.H6) device evaluation: a medtronic representative went to the site to test the equipment.Testing revealed that the door cable guides were sheared.Repaired cable guide mounts, replaced tractor drive and damaged door winch assemblies.The imaging system then passed the system checkout and was found to be fully functional.B01, c07, d02 are applicable.Img component code).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

Additional information was received.The system gantry doors would not open, and the system was moved to the bottom of the bed near the patient while the procedure was finished.Once the procedure was done, the patient was able to be taken off of the bed while the system was still around the bottoms portion of the bed.Once the patient was removed, the staff took the bed apart so that the imaging system could be removed from the room.

Manufacturer Narrative

H2) device evaluation: h3, h6 = the winch assembly was returned to the manufacturer for analysis.Analysis found that the winch motor assembly with motion cart, forward and backwards motion passed, brake was engaging and disengaging as normal.Visual inspection showed the door winch center cog gear shaft was bent, still functional and normal wear on the rest of the assembly.It was a damaged door winch assembly.Analysis found that the reported event was related to a physical damage issue.B01, c07, d02 are applicable.H3, h6: the tractor drive assembly was returned to the manufacturer for analysis.Analysis found that the tractor drive assembly with motion cart, forward and backwards motion passed, brake was engaging and disengaging as normal.Visual inspection shows damaged teeth on the drive belt.It was a damaged assembly.Analysis found that the reported event was related to a physical damage issue.B01, c07, d02 are applicable.H2) additional information: b5 updated.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.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16462724
• MDR Text Key: 310503217
• Report Number: 3004785967-2023-00128
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG