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: KARL STORZ SE & CO. KG RESECTOSCOPE SHAFT, 27 CHARR
  • 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
 

KARL STORZ SE & CO. KG RESECTOSCOPE SHAFT, 27 CHARR Back to Search Results
Model Number 27241AO
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.
 
Event Description
The reported event occurred in germany.During a case, the ceramic tip broke off inside the patient.The fragment could be retrieved.The case could be completed with another instrument.No injury to a patient, user, or third was reported.Internal karl storz reference number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESECTOSCOPE SHAFT, 27 CHARR
Type of Device
RESECTOSCOPE SHAFT, 27 CHARR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key15860876
MDR Text Key304286891
Report Number2020550-2022-00313
Device Sequence Number1
Product Code FBO
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2022,11/24/2022
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 Model Number27241AO
Device Catalogue Number27241AO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/18/2022
Device Age12 YR
Event Location Hospital
Date Report to Manufacturer11/18/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-