MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG PNEUMO SURE HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620040600
Medical Device Problem Codes	Increase in Pressure (1491); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that during a case the insufflator was not giving an accurate pressure or flow reading that caused over distension of the patient.They had to shut the insufflator off and start an open case.
Additional Manufacturer Narrative
According to what was reported, the device was not available for evaluation.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: inaccurate pressure or flow reading.Probable root cause: 1.Pressure sensor malfunction / out of calibration.2.Software malfunction.3.Use error.4.System design.5.Unwanted movement of internal components / wiring.6.Pressure button does not disengage.7.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.8.Venting valve system or overpressure alarm failure.9.Safety valve or regulator malfunction.10.Hpu or lpu assembly malfunction.11.Ppv failure.The reported failure mode will be monitored for future reoccurrence.Added initial reporter phone number and initial reporter postal code.
Event or Problem Description
It was reported that during a case the insufflator was not giving an accurate pressure or flow reading that caused over distension of the patient.They had to shut the insufflator off and start an open case.

• Brand Name: PKG PNEUMO SURE HIGH FLOW INSUFFLATOR
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21860549
• Report Number: 0002936485-2025-00349
• Device Sequence Number: 7842122
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• 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): 07/02/2025

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: 0620040600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2007
• 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