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

Model Number 091361-06

Device Problems No Display/Image (1183); Optical Distortion (3000)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported on feburary 27, 2023 that :during a veterinary intervention, image failure 5 minutes into the procedure.No harm to patient, user or third parties.Further information received on the march 14, 2024 that the bronchoscopy had to be aborted and the lung wash was performed blind.Due to the additional information and the mentioned change of the surgical procedure, the risk for serious deterioration in state of health is not negligible.Thus, a report is required.

Manufacturer Narrative

Correction was made in section b1 to reflect that this is a serious injury and not a malfunction as the initial report stated.As the device in question was not returned by the customer, an investigation on the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 2024-04-15.The evaluation based on the provided information revealed the following: the customer describes that within minutes the image was distorted when going close to tissue.After internal discussions with a sme, the described distorion is most likely a normal behaviour of the endoscope when it is brought to close to an object.It gets out of focus and the picture gets distorted to a certain degree.Furthermore, the device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot nor the article number.There is no indication for a manufacturing or design related error.Based on the provided information and without a device for investigation, a product problem is excluded.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FIVE S 3.5X65, STERILE, FOR SINGLE USE
• Type of Device: FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE,
• 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: 18926516
• MDR Text Key: 337929820
• Report Number: 9610617-2024-00073
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 4048551422519
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 091361-06
• Device Catalogue Number: 091361-06
• Device Lot Number: 500098519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other