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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY HOPKINS RIGID TELESCOPE

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KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY HOPKINS RIGID TELESCOPE Back to Search Results
Model Number 26120BA
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/05/2017
Event Type  Malfunction  
Manufacturer Narrative

Scope has not been returned for evaluation.

 
Event Description

Allegedly, the doctor was performing a d & c hysteroscopy with ablation on patient, when she removed scope from uterus and noticed a piece of the scope distal window was cracked and missing. They brought in another scope and completed procedure. Doctor went back in to check if piece was inside patient. She didn't find it; no x-ray was performed. Doctor doesn't have plans to schedule another procedure to locate missing piece. She believes that it was flushed out during irrigation. The hospital reported there was no injury to the patient.

 
Manufacturer Narrative

The distal window seal is broken. Possible causes can be the epoxy coming undone on distal lens window. Excessive or prolonged heat will cause this along with trauma to the instrument distal tip. We cannot confirm cause.

 
Event Description

This is a supplemental. I will be adding method/results/conclusion codes and evaluation of the instrument.

 
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Brand NameHOPKINS RIGID TELESCOPE
Type of DeviceRIGID TELESCOPE
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
mittlestrasse 8,
78503
tuttlingen, germany,
GM
Manufacturer (Section G)
KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
mittlestrasse 8,
78503
tuttlingen, germany,
GM
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188519
MDR Report Key6613568
MDR Text Key76740291
Report Number9610617-2017-00041
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK943176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number26120BA
Device Catalogue Number26120BA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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