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 Code	Bradycardia (1751)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient became bradycardic.Set pressure was lower than usual setting according to the surgeon (pressure at 12mmhg, flow at 20l/min).
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the patient became bradycardic.Set pressure was lower than usual setting according to the surgeon(pressure at 12mmhg, flow at 20l/min).
Additional Manufacturer Narrative
Although product was logged as received, the product will be held at endo until it is cleared to ship to wom in sarasota florida.In the event that the device is returned to wom, the complaint will be re-opened, and the investigation will be updated with the new results.The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: issue with flow rate, pressures and alerts for low gas rates.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): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25288813
• Report Number: 25288813
• Device Sequence Number: 9541056
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026
• Report Date (Section F): 08/14/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2026
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 187 LB