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, 5MM PEEK HANDLE, 45CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
  • 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, 5MM PEEK HANDLE, 45CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED Back to Search Results
Catalog Number 0250181164
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
 
Event Description
It was reported that the insulation had been compromised.
 
Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: surgery insulation.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.Manufacture date is not known.
 
Event Description
It was reported that the insulation had been compromised.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PKG, 5MM PEEK HANDLE, 45CM
Type of Device
ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7513024
MDR Text Key108366694
Report Number0002936485-2018-00424
Device Sequence Number1
Product Code OCZ
Combination Product (y/n)N
PMA/PMN Number
K973259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0250181164
Device Lot Number1344251H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Date Manufacturer Received04/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-