MAUDE Adverse Event Report: Stryker Leibinger Freiburg Precision pointer Electromagnetic; Ear, Nose, and Throat Stereotaxic Instrument

Catalog Number	8000-050-001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a new precision pointer (first use) was inaccurate during patient registration, displaying a position approximately one inch off bone when touching the patient's lateral canthi.The pointer was replaced and the issue was resolved.A surgical delay of 10 minutes was reported.No adverse consequences or any medical intervention were reported at intake.

• Brand Name: Precision pointer Electromagnetic
• Common Device Name: Ear, Nose, and Throat Stereotaxic Instrument
• Manufacturer (Section D): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50683603
• Report Number: 0008010177-2026-00165
• Device Sequence Number: 16072599
• Product Code: PGW
• UDI-Device Identifier: 07613327413205
• UDI-Public: 07613327413205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Catalogue Number: 8000-050-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown