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

Catalog Number	0620040600
Medical Device Problem Codes	No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was loss of insufflation during procedure.
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.
Event or Problem Description
It was reported there was loss of insufflation during procedure.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: output issue confirmed failure: leaking, calibration, software upgrade.Probable root cause: 1.System design.2.Use error.3.Service error.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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: 18862106
• Report Number: 0002936485-2024-00202
• Device Sequence Number: 15497114
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 0620040600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown