• 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. 24FR. 30º CUTTING LOOP ELECTRODE, .014 CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

  • 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. 24FR. 30º CUTTING LOOP ELECTRODE, .014 CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0504880414
Device Problems Electrode (451); Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/15/2017
Event Type  Injury  
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 broken pieces of the sheath and electrode remained inside the patient.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePKG. 24FR. 30º CUTTING LOOP ELECTRODE, .014
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
valerie estrada
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6476286
MDR Text Key72242280
Report Number0002936485-2017-00366
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeIR
PMA/PMN NumberK040390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0504880414
Device LOT NumberSTRIL03
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/10/2017 Patient Sequence Number: 1
-
-