MAUDE Adverse Event Report: KARL STORZ SE & CO.KG BIPOLAR CUTTING LOOP

Model Number 26040GP1

Device Problem Material Separation (1562)

Patient Problem Fibrosis (3167)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

The electrode has not been returned, therefore; the product could not be evaluated.

Event Description

Allegedly, during a hysteroscopic myomectomy procedure, 2-3 mm of the bipolar electrode loop broke due to the resistance of the large fibroma.No additional information has been provided regarding the outcome to the patient.

• Brand Name: BIPOLAR CUTTING LOOP
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10317093
• MDR Text Key: 200427275
• Report Number: 9610617-2020-00084
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 04048551392720
• UDI-Public: 4048551392720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26040GP1
• Device Catalogue Number: 26040GP1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR