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

Model Number	0620040600
Medical Device Problem Codes	No Flow (2991); Pressure Problem (3012)
Health Effect - Clinical Codes	Peritoneal Laceration(s) (2003); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
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 that the case was delayed a few days due to loss of insufflation during procedure.
Event or Problem Description
It was reported that the case was delayed a few days due to loss of insufflation during procedure.
Additional Manufacturer Narrative
Alleged failure: cib, levian, rep, calibration or something wrong with the flow, wcb.*update: loss of insufflation for a little during a case until worked for a while and then stopped working properly after case was over.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be third party repair.The unit is also past due for calibration.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 16792208
• Report Number: 0002936485-2023-00337
• Device Sequence Number: 5679281
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/16/2024

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 Model Number: 0620040600
• Device Catalogue Number: 0620040600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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