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

Model Number BI70002000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: no parts have been received by the manufacturer for evaluation.Concomitant medical products: other relevant device(s) are: product id: bi71000529, serial/lot #: unk ; product id: bi71000194, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used during a l3-l4 transforaminal lumbar interbody fusion (tlif) procedure.It was reported that following an initial successful 2d image acquisition, no additional image acquisitions could be performed.It was noted the issue was with both 2d and 3d imaging.Following a reboot, the imaging system booted into e-stop functionality where it could not be cleared.A secondary pendant was setup to clear the error but the primary pendant could not be reset.The surgeon opted to complete the procedure without the use of the navigation system.The surgeon opted to complete the procedure without the use of the imaging system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.Post-operative troubleshooting found that the handswitch for the imaging system was damaged.Additionally, it was noted image acquisitions were not attempted with the footswitch intra-operative.Battery voltages on the imaging system were also confirmed to be within specification.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could be replicated.The representative then returned to the facility at a later date and replaced the pendant and 135 degree cover on the imaging system.The imaging system then passed the system checkout and was found to be fully functional.Continuation of d10) pn: bi71000159, ln/sn: unk.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

The pendant was returned to the manufacturer for analysis.The pendant was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The x-ray hand switch was returned to the manufacturer for analysis.Analysis found that after installing the hand switch into a test system, it was unable to acquire an image with both the 2d and 3d buttons on the hand switch.The store function was functioning correctly.Analysis found that the reported event was related to a electrical issue.Fdm b01, fdr c19, c02 and fdc d14, d02 are applicable to the hardware analysis.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: 14021061
• MDR Text Key: 288667350
• Report Number: 3006544299-2022-00094
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2022

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: 04/04/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 04/05/2022; 07/25/2022
• Supplement Dates FDA Received: 04/26/2022; 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 80 KG