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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 Unable to Obtain Readings (1516)
Patient Problem No Code Available (3191)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that the device was not reading the correct pressure.The patient experienced hypercapnia.The procedure was completed successfully.
 
Manufacturer Narrative
The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be a missing o-ring on the adapter which could have caused fluctuations in pressure and may cause the correct pressure to not be indicated correctly on the insufflator.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that the device was not reading the correct pressure.The patient experienced hypercapnia.The procedure was completed successfully.
 
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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
MDR Report Key7741034
MDR Text Key115786234
Report Number0002936485-2018-00563
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
PMA/PMN Number
K063367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/30/2018
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 Number0620040611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Initial Date Manufacturer Received 07/05/2018
Initial Date FDA Received08/01/2018
Supplement Dates Manufacturer Received07/05/2018
Supplement Dates FDA Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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