• 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 GERMANY 27 FRENCH OBTURATOR 27 FRENCH OBTURATOR RESECTOSCOPE

  • 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 GERMANY 27 FRENCH OBTURATOR 27 FRENCH OBTURATOR RESECTOSCOPE Back to Search Results
Model Number 27040AK
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/20/2017
Event Type  Injury  
Event Description

Ceramic obturator end broke off during procedure. The physician was unable to retrieve the remaining piece. The remnant piece was retained in the bladder. On(b)(6) 2017, the surgeon performed a second surgical procedure to retrieve the retained piece. The surgery was successful. The company is aware. Ccn, cms (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name27 FRENCH OBTURATOR
Type of Device27 FRENCH OBTURATOR RESECTOSCOPE
Manufacturer (Section D)
KARL STORZ GERMANY
14 mechanics st.
southbridge MA 01550
MDR Report Key6767187
MDR Text Key82022347
Report NumberMW5071374
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number27040AK
Device LOT NumberTX01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/03/2017 Patient Sequence Number: 1
-
-