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

Model Number 27040GP1-S

Device Problems Material Fragmentation (1261); Material Frayed (1262); Arcing of Electrodes (2289); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Product requested but not yet received.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The malfunction is filed under internal complaint id (b)(4).

Event Description

According to the information received during the case, using the resectoscope during hysteroscopy, the bipolar cutting loop started to fray, melt, and created a spark.No change to patients' status and didn't cause any further complications during the case.

Manufacturer Narrative

Per the salesrep, product will not be returned for evaluation.Product was thrown out.

• Brand Name: BIPOLAR ELECTRODE 24/26 FR
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA
• MDR Report Key: 16022330
• MDR Text Key: 308174966
• Report Number: 9610617-2022-00331
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• 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 Sex: Female