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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG 24/26FR BIPOLAR CUTTING LOOP; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

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KARL STORZ GMBH & CO. KG 24/26FR BIPOLAR CUTTING LOOP; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) Back to Search Results
Model Number 26040GP1-S
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2022
Event Type  malfunction  
Event Description
Diagnostic hysteroscopy, myomectomy using blue light tower generator with gyn resecting loop 24/26fr, ref #(b)(4) lot #37ka9270.The loop broke during resection.Surgeon verified the loop was complete and no retained items were left in the patient.
 
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Brand Name
24/26FR BIPOLAR CUTTING LOOP
Type of Device
COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG
2151 e grand ave
el segundo CA 90245
MDR Report Key14279873
MDR Text Key290672030
Report Number14279873
Device Sequence Number1
Product Code HIN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/27/2022
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 Number26040GP1-S
Device Lot Number37KA9270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2022
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer05/04/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/04/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age15330 DA
Patient SexFemale
Patient Weight83 KG
Patient RaceWhite
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