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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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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.

 
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Type of DeviceCYSTOSCOPE 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
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
Device MODEL Number27033A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
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 The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/13/2017 Patient Sequence Number: 1
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