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

Model Number 26040GP1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

The electrode has not been returned for evaluation.

Event Description

Allegedly, during a hysteroscopic myomectomy procedure, the bipolar electrode loop broke and the doctor requested the myosure tissue removal system and subsequently found a small piece of loop from the electrode inside the myosure tissue removal system.They confirmed all pieces had been removed and there was no patient harm.

• 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 east grand avenue; el segundo, CA 90245-5017
• MDR Report Key: 8259001
• MDR Text Key: 133485186
• Report Number: 9610617-2019-00012
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 64