MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR; RIGID ENDOSCOPE WORKING GUIDE

Model Number 26040EB

Device Problem Mechanical Problem (1384)

Patient Problem Burn(s) (1757)

Event Date 02/28/2019

Event Type  Injury  

Event Description

It was reported that there was event with a "working element".According to the information received, the patient got intra uterine burns - as well as a burn on inside of the leg.Both did not lead to any further complication and has not been recognized by the patient (statement of the staff).Further information is not available.

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)).The bi-polar loop is completely bent.This lead to a narrow position of the current transporting parts to the outer retroscope sheath.The provided hf cable shows a shortcut.The plug took on the working element is worn out and third party repaired.Bent loop should have been taken out of service due to the damages - ifu gives clear advice not to use them.The plug fixation does not work on the working element - therefore the plug was not fixed proper and created a shortcut to the working element.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Type of Device: RIGID ENDOSCOPE WORKING GUIDE
• 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: 17210111
• MDR Text Key: 317987324
• Report Number: 9610617-2023-00845
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 26040EB
• Device Catalogue Number: 26040EB
• Device Lot Number: NU09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2015
• 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
• Treatment: 26040GP1 CUTTING LOOP, BIPOLAR, 26 FR.; 26050CA INNER SHEATH FOR RESECTOSCOPE; 26050SC RESECTOSCOPE SHEATH, 26 FR.; 27176LEB BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Patient Outcome(s): Other
• Patient Sex: Female