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

Model Number 11303BNXK

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The item was evaluated and found the vertebrae was soiled caused by corrosion.This is due to maintenance and care."the customer clinical engineer brought this to our attention after two scope failures, even though they were fairly certain this was caused by too large of a scope for the ett.".

Event Description

Allegedly, in early (b)(6) 2020, during a procedure the intubation video scope was damaged during a procedure resulting in piece(s) of the rubber sheath of the distal tip being left inside the patient.

• Brand Name: FLEX. INTUBATION VIDEO SCOPE 5.5 X 65 CM
• Type of Device: VIDEO INTUBATION
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11167583
• MDR Text Key: 232530465
• Report Number: 1221826-2021-00008
• Device Sequence Number: 1
• Product Code: CAL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2020

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: 11303BNXK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other