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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UROLOGY INNER SHEATH; INNER RESECTOSCOPE SHEATH
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KARL STORZ SE & CO. KG UROLOGY INNER SHEATH; INNER RESECTOSCOPE SHEATH Back to Search Results
Model Number 27050CA
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for evaluation by the facility, therefore; no evaluation cause or findings can be obtained.
 
Event Description
The manufactures reference number is (b)(4).The instrument broke inside the patient during a procedure.The surgeon was able to retrieve the instrument from the patient and the patient did not suffer any trauma.It happened towards the end of the procedure so there was only a delayed of approximately 5 minutes.
 
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Brand Name
UROLOGY INNER SHEATH
Type of Device
INNER RESECTOSCOPE SHEATH
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen, gm,
GM 
MDR Report Key15748900
MDR Text Key303230339
Report Number2020550-2022-00296
Device Sequence Number1
Product Code FBO
UDI-Device Identifier04048551077412
UDI-Public4048551077412
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27050CA
Device Catalogue Number27050CA
Device Lot NumberXR02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2022
Distributor Facility Aware Date10/11/2022
Event Location Hospital
Date Report to Manufacturer11/04/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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