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

Model Number 26040GP

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.The cutting loop is completely bent.The neutral electrode is melted off - as is the insulation.The cutting loop was bent - this probably meant that the minimum distance between the electrodes was no longer maintained and the entire area was thermally damaged by the short circuit.An operator error is assumed.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a cutting loop, bipolar.According to the information received, the hysteroscopic myomectomy was performed under general anaesthesia.After half of the fibroid resected, the cutting loop was found to be broken.After removal of the instrument for examination, <0.5cm metal part of the cutting loop was missing.As an immediate action an inspection for the concerned cutting loop on site was performed.X-ray for checking up after operation was also performed.The missing part has not been found in patient's body.Information about patients health was not provided.Additional patient information is not available.

• Brand Name: CUTTING LOOP, BIPOLAR
• Type of Device: CUTTING LOOP, 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: 17210115
• MDR Text Key: 317964215
• Report Number: 9610617-2023-00858
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 06/20/2023

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: 26040GP
• Device Catalogue Number: 26040GP
• Device Lot Number: WU09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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