MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC

Model Number 9734056

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of concomitant products: information references the main component of the system. Other relevant device(s) are: product id: 9733437, serial/lot #:(b)(4), ubd: unknown, udi#: (b)(4). This event took place in (b)(6). A medtronic representative visited the site to evaluate the equipment. Hardware parts were replaced. Codes b01, c07, and d02 are applicable. The returned psu had no noise when powered up on the test bench. A check of the event log did not show any adverse events. However, the psu did fail an accuracy test (aak) at. 40 mm with a passing threshold of. 35 mm. Codes b01, c13, and d02 are applicable. The returned scu was analyzed, but no failures were found. Codes b01, c19, and d14 are applicable. The returned ups was analyzed, but no failures were found. Codes b01, c19, and d14 are applicable. The returned axiem was analyzed, but no failures were found. Codes b01, c19, and d14 are applicable. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information while servicing the imaging system. It was observed that a noise was generated during inspection of the system. No patient involvement was reported. Additional information was received. It was reported that there was no indication as to where the noise was coming from.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11739638
• MDR Text Key: 248643412
• Report Number: 1723170-2021-01138
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/09/2021
• 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