MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM

Model Number 495NAC

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that the light was switched on without the other end of the cord being plugged into the scope.This resulted in a small hole in the drape near the patient's lower extremities.The patient was assessed, and no harm had reached the patient.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

This report is to correct the produict code from fcw to the correct product code of oay.The event is filed under internal karl storz complaint id: 968350.

• Brand Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Type of Device: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17703269
• MDR Text Key: 322889358
• Report Number: 9610617-2023-00249
• Device Sequence Number: 1
• Product Code: OAY
• UDI-Device Identifier: 04048551290705
• UDI-Public: 4048551290705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 495NAC
• Device Catalogue Number: 495NAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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