MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG PATIENT TRACKER ELECTROMAGNETIC; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 8000-040-001

Device Problem Incorrect Measurement (1383)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

While being used in a case, the device was inaccurate.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.

Manufacturer Narrative

Update: d9, h3, h6.Device evaluation: follow-up report submitted to document the device evaluation.

Event Description

While being used in a case, the device was inaccurate.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: PATIENT TRACKER ELECTROMAGNETIC
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19153082
• MDR Text Key: 341273175
• Report Number: 0008010177-2024-00031
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 07613327413229
• UDI-Public: 07613327413229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2024

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 Catalogue Number: 8000-040-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 07/08/2024
• Supplement Dates FDA Received: 07/08/2024
• 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