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

Device Problem Incorrect Measurement (1383)

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

Event Date 03/08/2024

Event Type  malfunction  

Event 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
• 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: 18943527
• MDR Text Key: 338448431
• Report Number: 0008010177-2024-00020
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 07613327413199
• UDI-Public: 07613327413199
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 03/20/2024

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: 8000-020-002
• Device Lot Number: VERSION 3.4.5
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/20/2024
• 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