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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, ROTATABLE; ENDOSCOPE SHEATH
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KARL STORZ SE & CO. KG INNER SHEATH, ROTATABLE; ENDOSCOPE SHEATH Back to Search Results
Model Number 26050XA
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2023
Event Type  Injury  
Event Description
It was reported that while doing a resection under a gynae list.Where the karl storz gynae resectoscope sheath has melted and the ceramic beak has broken.Fortunately, the patient and safe and all debris were retrieved inside the patient's cavity.It was stated that a medical/surgical intervention was required to retrieve the broken parts.No death or (unanticipated) serious deterioration in state of health reported.Due to the medical intervention, a report is required.
 
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
INNER SHEATH, ROTATABLE
Type of Device
ENDOSCOPE SHEATH
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key18156272
MDR Text Key328356911
Report Number2020550-2023-00375
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04048551092668
UDI-Public4048551092668
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26050XA
Device Catalogue Number26050XA
Device Lot NumberON03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2023
Event Location Hospital
Date Report to Manufacturer11/16/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/16/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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