MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIVE S 3.5X65, STERILE, FOR SINGLE USE,

Model Number 091361-06

Device Problem Optical Problem (3001)

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

Event Date 01/05/2020

Event Type  malfunction  

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 returned for investigation.Evaluation findings: defect location: video scope/ control wire & interface board.Defect type: ragged & no image.Cause code: not included/ failure not classifiable.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that when plugged directly into the ebox it would not show an image until articulated.

• Brand Name: FIVE S 3.5X65, STERILE, FOR SINGLE USE,
• Type of Device: FIVE S 3.5X65, STERILE, FOR SINGLE USE,
• 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: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17999736
• MDR Text Key: 326497665
• Report Number: 9610617-2023-00320
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 4048551422519
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 091361-06
• Device Catalogue Number: 091361-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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