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

Model Number 27040GP1

Device Problem Mechanical Problem (1384)

Patient Problem Burn(s) (1757)

Event Date 12/22/2017

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).On the electrode, the working side and neutral electrode are bent.This means that the distance to the metal parts in the resectoscope is no longer given and the hf current could pass through to the shaft.Furthermore, the cutting loop is torn out of its anchorage on one side.The bending allowed the current to flow over the shaft and cause local burns, and the cutting electrode was able to catch in the inner shaft.The instructions for use contain a detailed explanation of the situation and corresponding warnings.

Event Description

It was reported that there was event with a "cutting loop".According to the information received: patient incident without serious consequences.During surgery (operative hysteroscopy) on a patient on (b)(6) 2017, it was observed that part of the 27040gp bipolar loop of the hamou resector (bipolar hysteroscope) appeared to have disengaged at its tip.This was replaced at the end of the procedure by the 27040 nb spherical bipolar loop, which worked perfectly.At the end of the procedure, the patient was found to have a burn on the vulvar fork.This patient is being followed up for this burn.Further information is not available.

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• 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: 17225782
• MDR Text Key: 318114241
• Report Number: 9610617-2023-00854
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122983
• 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: 06/28/2023

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: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: WT24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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
• Patient Sex: Female