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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 W SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC
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STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620040611
Device Problem Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2023
Event Type  malfunction  
Event Description
It was reported that there was loss of insufflation during procedure.
 
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.
 
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Brand Name
PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1)
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
lucas wolski
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key18341223
MDR Text Key330677995
Report Number0002936485-2023-01271
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0620040611
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? No
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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