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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 4 MM, 30 CM RIGID HYSTEROSCOPE

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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 4 MM, 30 CM RIGID HYSTEROSCOPE Back to Search Results
Model Number 26105BA
Device Problem Use of Device Problem (1670)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 06/17/2019
Event Type  Injury  
Manufacturer Narrative

The device was evaluated by the manufacturer, (b)(4). As per the evaluation: the fiber optics are partially damaged and the optics show corrosion. A reason for the damaged fibers could be hitting or bending of the optics. Corrosion can be caused by incorrect preparation / incorrect drying. A root cause for the described failure could be a longer application, which leads to a heat development [overheating]. This can cause burns if the light cable is placed directly on the patient. The ifu points out that a light cable shouldn't lay directly on the patient. The damage of the product is not caused by a production problem or material defect.

 
Event Description

As per a vigilance report received from the factory in (b)(4), a patient received a burn on the inner aspect of the left thigh thought to have occurred by the end of the hysteroscope coming into contact with the patient's leg when the power was on. The lesion was roughly the same size as the hysteroscope tip (4 - 5mm). Accessing the endometrial cavity was difficult and the operators were switching between using the hysteroscope to facilitate dilatation, and hegar dilators. When the hysteroscope was not being actively used, it was placed on the patient's abdomen. The consultant would usually ask a member of the nursing team in theatre to turn the power off when the hysteroscope is not being actively used, but in this case, possibly because there was continual switching between means of dilating the cervix, this does not seem to have been the case. Once the injury was identified, the medical and nursing teams inspected the drapes but found no evidence of charring or burning. Patient assessed at the burns clinic the following day. The burn was found to be full thickness, and the patient went to surgery there for excision and primary closure of the lesion. She was discharged the following day.

 
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Brand NameHOPKINS TELESCOPE 30°, 4 MM, 30 CM
Type of DeviceRIGID HYSTEROSCOPE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key9679558
MDR Text Key178095642
Report Number9610617-2020-00017
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK943176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number26105BA
Device Catalogue Number26105BA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/28/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/06/2020 Patient Sequence Number: 1
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