MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG SCOPIS ENT SW WITH TARGET GUIDED SURGERY; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	8000-020-002
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the account, the accuracy of the device deteriorates while in use.After initial registration, accuracy of the instrumentation is within specification.However; after about a half hour of use, the image data deviates considerably from the actual patient anatomy in the axial view "axis".After the operation, it was found that three of the five anatomical landmarks had deviations that were well above 1.5 mm.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
Per the account, the accuracy of the device deteriorates while in use.After initial registration, accuracy of the instrumentation is within specification.However; after about a half hour of use, the image data deviates considerably from the actual patient anatomy in the axial view "axis".After the operation, it was found that three of the five anatomical landmarks had deviations that were well above 1.5 mm.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: SCOPIS ENT SW WITH TARGET GUIDED SURGERY
• Common Device Name: 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: 18943527
• Report Number: 0008010177-2024-00020
• Device Sequence Number: 20890965
• Product Code: PGW
• UDI-Device Identifier: 07613327413199
• UDI-Public: 07613327413199
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K221098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 8000-020-002
• Device Lot Number: VERSION 3.4.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown