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	Insufficient Information (4580)
Date of Event	09/09/2025
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 by the customer that when they plugged in the insufflation tubing to the machine and selected the pressure and flow settings but had not yet pressed start, a message came up.Upon hitting start, the settings for the pressure were set at 12 and the number climbed to 30 (even with the 12 setting).It was further reported that the patient's stomach was very hard and the trocar had to be released to let the co2 out.After turning the machine off and then back on, it worked fine.
Event or Problem Description
It was reported by the customer that when they plugged in the insufflation tubing to the machine and selected the pressure and flow settings but had not yet pressed start, a message came up.Upon hitting start, the settings for the pressure were set at 12 and the number climbed to 30 (even with the 12 setting).It was further reported that the patient's stomach was very hard and the trocar had to be released to let the co2 out.After turning the machine off and then back on, it worked fine.Multiple attempts were made for additional information regarding completion of surgery, surgical delay, medical intervention, and adverse event details, however no new information was received.
Additional Manufacturer Narrative
The product was not returned for investigation as it is reported to remain in the field therefore the reported failure mode was not confirmed.Alleged failure: pressure and flow settings issue.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 ; 4087542000
• MDR Report Key: 23304588
• Report Number: 0002936485-2025-00838
• Device Sequence Number: 13268931
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025
• Report Date (Section F): 10/15/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/15/2025