MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 STAFF ASSEMBLED; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problems Human-Device Interface Problem (2949); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9733575, serial/lot #: unk.A medtronic representative went out to the site and found a hardware failure noting that the camera localizer was not responding.They replaced the camera localizer cable to main cart, and now the localizer is working now and instruments tracking correctly.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used outside of a procedure.It was reported that the site was having intermittent "localizer not connected " behavior issues.There was no patient involved.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Initial reporter was a biomed from the site.Name of initial reporter unknown at the time of report.The cable 9733575 ext scu to r/a psu (170928) was returned for analysis.Analysis found that the cable had been pinched near the right angle connector, but was otherwise intact.The cable passed a continuity test with no opens or shorts detected.There was no problem found.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: S7 STAFF ASSEMBLED
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9934363
• MDR Text Key: 186817108
• Report Number: 1723170-2020-01173
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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