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

Catalog Number	0620040610
Medical Device Problem Codes	Increase in Pressure (1491); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
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 there was overpressure during procedure.
Event or Problem Description
It was reported that there was overpressure during procedure.
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: actual pressure on the unit was reading 0 and the insufflator kept insufflating.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.12.Manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.The manufacture date is not known.

• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19818170
• Report Number: 0002936485-2024-00517
• Device Sequence Number: 15630525
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/02/2024

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: 06/25/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2010
• 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