MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEX. INTUBATION VIDEO SCOPE 5.5 X 65 CM

Model Number 11301BNXK

Device Problem Insufficient Information (3190)

Patient Problem Transmissible Spongiform Encephalopathy(TSE) (4556)

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

We are currently trying to gather additional information related to the product, event and patient condition.The device was returned in a biohazard bag and quarantined at our canadian facility, and the device will later be destroyed (for safety reasons) without further evaluation or testing.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case # (b)(4).

Event Description

Customer has learned on (b)(6) 2023 that a user (patient) who received care at their facility between 2017 and 2021 has recently been diagnosed with creutzfeldt-jakob disease.Per customer, the patient underwent a thoracic surgery, on (b)(6) 2018, for which a 5.5 mm adult video endoscope 11301bnx (# series (b)(6) was used.The patient was asymptomatic at that time.

Manufacturer Narrative

The manufacturer concluded their findings as shown below: the device was quarantined at ksec (canada) and ultimately destroyed for safety reasons.Therefore, a thorough evaluation of the product was not performed, and root cause analysis could not be determined.Per risk acceptance criteria (c2.2.1.0001.Wi001 rev.Bc), (b)(4), therefore, no change to the overall occurrence level and overall risk rating.No capa/further action necessary.

• Brand Name: FLEX. INTUBATION VIDEO SCOPE 5.5 X 65 CM
• Type of Device: FLEX. INTUBATION VIDEO SCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo 90245 ; 4242188247
• MDR Report Key: 17210220
• MDR Text Key: 317942574
• Report Number: 1221826-2023-00127
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551314692
• UDI-Public: 4048551314692
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: E308890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 11301BNXK
• Device Catalogue Number: 11301BNXK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 08/09/2023
• 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
• Patient Outcome(s): Disability; Life Threatening