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 ENDOSCOPY-AMERICA, INC; 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
 

KARL STORZ ENDOSCOPY-AMERICA, INC; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 27033A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 12/12/2016
Event Type  Injury  
Event Description
Patient was scheduled for a cystoscopy with transurethral incision of posterior urethral valves and a circumcision.During the cystoscopy, the patient became hemodynamically unstable and the procedure was stopped.The patient was stabilized and transferred to the pediatric intensive care unit (picu) where he continued to decompensate.After approximately three hours, he returned to the operating room for a stat exploratory laparotomy and it was discovered that the left iliac vein and artery were lacerated.The vessels were immediately clamped to control bleeding.The vascular team was contacted, and the artery was repaired without difficulty.The patient improved immediately and was readmitted to the picu for four days.He was later transferred to an inpatient room and discharged eleven days after admission.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC
2151 e. grand avenue
el segundo CA 90245
MDR Report Key6398643
MDR Text Key69758415
Report Number6398643
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/25/2017,02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2017
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model Number27033A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer01/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight4
-
-