MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that this system would not open.This was discovered while it was around a patient.The door covers appeared to be misaligned, and the door override button and manual override were attempted without success.When the manual override was attempted, the door would begin to open and then stopped and provided too much resistance to move forward.The site was able to move the imaging system all the way to the patient's head and continue, but the patient had to be pulled from the table and table had to be partially disassembled to remove the imaging system from the room.The event caused a surgical delay of 45 minutes.There was no impact on patient outcome.

Manufacturer Narrative

Brand name ; product id bi71000429, product type: 3023-door motion (o2) mechanical co brand name ; product id bi71000273, product type: 3023-door motion (o2) mechanical co h3: the system was serviced in the field and the medtronic representative (rep) replaced all of the door slides inside of the gantry.They also performed a broken screw extraction on two of the slides.They cleaned all debris from the accident that caused the cables slides to break.They removed the gantry covers to perform adjustments on the door switches.It was stated that the door close/door open was an issue.They performed system checkout, and the system performed as intended.Codes b01, c07, d02 are applicable to this analysis.No parts have been received by the manufacturer for evaluation.Codes 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.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18015644
• MDR Text Key: 326649285
• Report Number: 3006544299-2023-00710
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000542849
• UDI-Public: 00763000542849
• 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
• Report Date: 10/26/2023

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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
• Treatment: SEE H10...
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 107 KG