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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE; CUTTING LOOP, BIPOLAR, 24/26 FR.

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KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE; CUTTING LOOP, BIPOLAR, 24/26 FR. Back to Search Results
Model Number 27040GP1
Device Problem Material Fragmentation (1261)
Patient Problem Insufficient Information (4580)
Event Date 07/11/2023
Event Type  Injury  
Event Description
It was reported that a customer reported to the italian authority that a resection loop broke during the procedure.The broken part migrated from the bladder in the abdominal cavity.There is no information whether the part was retrieved or not.There is also no information about the patient outcome.Thus, 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
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
Type of Device
CUTTING LOOP, BIPOLAR, 24/26 FR.
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key17759156
MDR Text Key323540042
Report Number2020550-2023-00256
Device Sequence Number1
Product Code FAS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/15/2023
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 Number27040GP1
Device Catalogue Number27040GP1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/13/2023
Event Location Hospital
Date Report to Manufacturer09/15/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/15/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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