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

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.

• 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 Key: 14279873
• MDR Text Key: 290672030
• Report Number: 14279873
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 26040GP1-S
• Device Lot Number: 37KA9270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White