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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC.; TUBING, INSUFFLATION

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KARL STORZ ENDOSCOPY-AMERICA, INC.; TUBING, INSUFFLATION Back to Search Results
Catalog Number 20400161S
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2018
Event Type  malfunction  
Event Description
Upon removing from sterile packaging, the storz high flow insufflation tubing with filter was cracked around the base near filter.
 
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Type of Device
TUBING, INSUFFLATION
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand avenue
el segundo CA 90245
MDR Report Key7921749
MDR Text Key122175594
Report Number7921749
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number20400161S
Device Lot Number133142
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2018
Event Location Hospital
Date Report to Manufacturer10/01/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/01/2018
Type of Device Usage N
Patient Sequence Number1
Patient Age14965 DA
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