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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC
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STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620040610
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2023
Event Type  malfunction  
Event Description
It was reported that there was inlet gas pressure issues during procedure.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
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Brand Name
PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR
Type of Device
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 Key17492999
MDR Text Key320754173
Report Number0002936485-2023-00791
Device Sequence Number1
Product Code HIF
UDI-Device Identifier07613327063295
UDI-Public07613327063295
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2023
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
Device Operator Health Professional
Device Catalogue Number0620040610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2023
Initial Date Manufacturer Received 07/14/2023
Initial Date FDA Received08/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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