MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SCOPIS ENT SOFTWARE WITH TGS; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 8000-020-002

Device Problem Incorrect Measurement (1383)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Per the customer, the device was inaccurate by 3mm during a surgical procedure.Additional information has been requested from the user facility.

Event Description

Per the customer, the device was inaccurate by 3mm during a surgical procedure.The procedure was completed successfully with the same device without a surgical delay; no medical intervention or adverse consequences were reported.

Manufacturer Narrative

The device log files were not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : only session and audit logs were provided, not device files.

• Brand Name: SCOPIS ENT SOFTWARE WITH TGS
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• 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: 15840139
• MDR Text Key: 304355473
• Report Number: 3015967359-2022-02330
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 07613327413199
• UDI-Public: 07613327413199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161491
• 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: 03/14/2023

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 Model Number: 8000-020-002
• Device Catalogue Number: 8000-020-002
• Device Lot Number: VERSION UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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