Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620040610
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was an error message for a high pressure reading during surgery, indicating overpressure.
 
Event Description
It was reported that there was an error message for a high pressure reading during surgery, indicating overpressure.
 
Manufacturer Narrative
Alleged failure: cib kk asr please eval error messages on system during case.Po sjc 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observed during the testing of the insufflator.However, the unit is of an older revision and has components that are outdated.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8525012
MDR Text Key142345585
Report Number0002936485-2019-00147
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 company representative
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
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 Manufacturer04/05/2019
Date Manufacturer Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-