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

Model Number 011160-10

Device Problem Energy Output Problem (1431)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4)).Upon examination the wire of the loop was found to be burned off.One of the yellow insulation rods is missing, the other shows signs of melting.The rods are strongly bent, the passive electrode is broken.The damage present on the returned electrode is most likely caused by mechanical stress and burnout of the wire.None - no indication for a product issue.A warning of overloading the instrument is described in the ifu.The handling is also described in the ifu.

Event Description

It was reported that there was event with a "electrode".According to the information received, a part of the loop remained in the patient's bladder.Further information is not available.

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, B
• 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: 17210116
• MDR Text Key: 317987225
• Report Number: 9610617-2023-00849
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: UQ64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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
• Treatment: 011160-01 ELECTRODE, BIPOLAR.; 27040DB WORKING ELEMENT, BIPOLAR.; 27176LEB BIPOLAR HIGH FREQUENCY CORD, 400 CM.
• Patient Outcome(s): Other