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

Model Number 27040DB

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.During investigation no failure was detected.The devices function as intended.No problem after change of gloves.The event is filed under internal karl storz complaint id (b)(4).

Event Description

T was reported that there was event with a working element.According to the information received, the storz bipolar resectoscope and autocon iii 400 (covered under a cpa sims) and the telescope became damaged during the case and was unusable.There was either damage to the lens system or to the distal tip - which will become apparent on inspection.Later on during the same case, the urologist received an electric shock on the hand when activating the cut/coag current.Additional information is not available.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Type of Device: WORK GUIDE FOR RIGID ENDOSCOPE
• 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: 16986848
• MDR Text Key: 316481622
• Report Number: 9610617-2023-00635
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: WS05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UH801 - BIPOLAR-HOCHFREQUENZKABEL.
• Patient Outcome(s): Other