MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR

Model Number 011050-10

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2023

Event Type  Injury  

Event Description

It was reported that the curved part of the handle has broken and detached in the patient's uterus.The part could not be found.It is considered that it was removed during the abrasion of the uterus during the removal of the compresses.Another device (of a different lot) was used to complete the intervention.This was therefore extended by 30 minutes.Since it is not confirmed that the broken part was removed, a report is required.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The investigation report was completed on august 2, 2023 due to the ductile break of the cutting loop, it is most likely that the loop got mechanically overloaded, broke, and created a shortcut to the neutral electrode resulted in melting down the wire.There is no material missing, just molten down and deposit on the neutral electrode.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR
• Type of Device: ELECTRODE, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17379327
• MDR Text Key: 319656885
• Report Number: 9610617-2023-00175
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011050-10
• Device Catalogue Number: 011050-10
• Device Lot Number: 839167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other