MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG SCOPIS ENT SW WITH TARGET GUIDED SURGERY; STEREOTACTIC SYSTEM APPLICATION SOFTWARE

Catalog Number	8000-020-002
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the account, during a case, the patient had a csf leak and the device was inaccurate.The surgeon was unclear if the device was the cause of the csf leak.The patient was sent to a hospital for further evaluation.Per the account an additional surgery was required to repair the csf leak.The additional procedure to repair the csf leak was completed successfully without a surgical delay; medical intervention or adverse consequences reported.
Event or Problem Description
Per the account, during a case, the patient had a csf leak and the device was inaccurate.The surgeon was unclear if the device was the cause of the csf leak.The patient was sent to a hospital for further evaluation.Per the account an additional surgery was required to repair the csf leak.The additional procedure to repair the csf leak was completed successfully without a surgical delay; medical intervention or adverse consequences reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.

• Brand Name: SCOPIS ENT SW WITH TARGET GUIDED SURGERY
• Common Device Name: STEREOTACTIC SYSTEM APPLICATION SOFTWARE
• 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: 19353965
• Report Number: 0008010177-2024-00046
• Device Sequence Number: 18008881
• Product Code: PGW
• UDI-Device Identifier: 07613327413199
• UDI-Public: 07613327413199
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• 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): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8000-020-002
• Device Lot Number: VER. 3.4.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown