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 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The item has not returned at this time.If the item is returned and evaluated, a supplemental will be submitted."the customer clinical engineer brought this to our attention after two scope failures and they were fairly certain this was caused by too large of a scope for the ett.".

Event Description

Allegedly, 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.

Manufacturer Narrative

The evaluation found the angle cover was torn 10mm - 12mm, and missing, at distal end behind the thread wrap.The distal shaft was crushed 175mm from distal tip and over bent under the stain relief on the proximal shaft, 30mm from the shaft adaptor.Also noted are scratches on the distal tip and a dent on working channel opening.The evaluation shows extensive mechanical damage that was likely caused by user error or handling.

• 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
• MDR Report Key: 11167548
• MDR Text Key: 227946425
• Report Number: 1221826-2021-00009
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• 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: 01/28/2021
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other