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

Model Number 11303BNXK

Device Problem Material Separation (1562)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Customer reported that the tip of the flexible intubation video scope came apart during an intubation procedure and lodged in patient's throat.The physician was able to retrieve the piece.There was no harm to patient, and they were able to continue the case with another instrument.

Manufacturer Narrative

The evaluation found angle cover tear 9 mm from distal tip, which caused a leak, and voids in epoxy at objective lens on distal face.Damages attributed to care and maintenance.

• Brand Name: FLEX. INTUBATION VIDEO ENDOSCOPE 5.5MM X 65CM
• Type of Device: FLEXIBLE VIDEO INTUBATION 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, CA 90245-5017 ; 4242188738
• MDR Report Key: 15112648
• MDR Text Key: 304623836
• Report Number: 1221826-2022-00131
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/27/2022

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: 11303BNXK
• Device Catalogue Number: 11303BNXK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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