MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PNEUMO SURE XL HG FLW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620040610
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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 the device did not respond adequately to the desired configuration, and it was observed that the patient was in the process of deflation.It was necessary to adjust the amount administered to maintain stability until the equipment was replaced.Therefore, there was loss of insufflation.
Additional Manufacturer Narrative
Per sales representative the device will not be returned 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: loss of insufflation during procedure 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.Power button inadvertently turned off 7.Tubeset/gas supply inadvertently detached/loose 8.Loss of power 9.Pressure button does not disengage 10.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge 11.Hpu or lpu assembly malfunction 12.Leaks from internal connections or seals 13.Ppv failure the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device did not respond adequately to the desired configuration, and it was observed that the patient was in the process of deflation.It was necessary to adjust the amount administered to maintain stability until the equipment was replaced.Therefore, there was loss of insufflation.

• Brand Name: PKG, PNEUMO SURE XL HG FLW 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22204448
• Report Number: 0002936485-2025-00537
• Device Sequence Number: 20554846
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Unknown