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

Catalog Number	0620040610
Medical Device Problem Codes	Increase in Pressure (1491); Output Problem (3005)
Health Effect - Clinical Codes	Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced edema due to overpressure.
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.
Additional Manufacturer Narrative
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: flowing heavy 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.The manufacture date is not known.
Event or Problem Description
It was reported that the patient experienced edema due to overpressure.

• Brand Name: PKG; PNEUMO SURE XL 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: 20741219
• Report Number: 0002936485-2024-00822
• Device Sequence Number: 12856206
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 0620040610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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