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; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); 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; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620040690
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/22/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tubing coming detached from the cassette.Probable root cause: system design (tolerance stack up issue).Manufacturing / assembly error.Use error.Damage during shipping (inadequate packaging).Damage during shipping (abuse during transit).The device manufacture date is not known.
 
Event or Problem Description
It was reported that the insufflation tubing disconnected during the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK)
Common Device Name
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key8289674
Report Number0002936485-2019-00040
Device Sequence Number1599123
Product Code HIF
UDI-Device Identifier37613327055659
UDI-Public37613327055659
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K003792
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/30/2019
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
Operator of Device Health Professional
Device Catalogue Number0620040690
Device Lot Number56005175
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/22/2018
Initial Report FDA Received Date01/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-