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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 Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that the insufflation stopped during the case.The procedure was completed successfully.
 
Event Description
It was reported that the insufflation stopped during the case.The procedure was completed successfully.
 
Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: cib (b)(6) rep.Stops insufflating during case.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as there were no issues observed during the testing of the insufflator.
 
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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
MDR Report Key8259111
MDR Text Key133481375
Report Number0002936485-2019-00028
Device Sequence Number1
Product Code HIF
UDI-Device Identifier07613327063295
UDI-Public07613327063295
Combination Product (y/n)N
PMA/PMN Number
K063367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
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 Manufacturer01/14/2019
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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