MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620050000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Insufficient Information (4580)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that pressure spiked towards the end of the case.It was further reported that patient coded.
Event or Problem Description
It was reported that pressure spiked towards the end of the case.It was further reported that patient coded.Additional information confirmed that the patient was stable after the procedure.
Additional Manufacturer Narrative
Additional information was updated in the executive summary and patient age was updated.The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: pressure spike.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): WORLD OF MEDICINE; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23851338
• Report Number: 0002936485-2025-00990
• Device Sequence Number: 15852933
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026
• Report Date (Section F): 12/17/2025

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: 0620050000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2021
• 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: Other
• Patient Age: 35 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/17/2025