MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE INTUBATION VIDEO ENDOSCOPE

Model Number 11301BNX

Device Problems Material Puncture/Hole (1504); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Our evaluation found an external cut at angle cover; approximately 11mm from tip with tool marks and cut marks at thread wrap epoxy causing a leak.There is a missing piece of angle cover; it measures approximately 4mmx4mm, there are scratches at the distal head, debris on the vertebrae, and scrape marks inside working channel.It appears that a sharp instrument of some type has cut into the distal head material and cut out a round section of the angle cover material.

Event Description

Allegedly, video scope was used during a procedure, when scope was inserted into a disposable tracheal tube and removed, a small piece of the distal black lining on scope may have stayed in the patient.The dr.Said that he could see the black piece near the lung area while intubating patient and thought it may be cancer, since patient already has a condition of terminal cancer.They called in a radiologist expert, but they couldn't find the black piece.The expert indicated that even if piece went down in lung, it wouldn't harm patient or pose a risk, since the piece is very small.Although they couldn't verify whether piece was in the patient, they continued and finished the procedure.

• Brand Name: FLEXIBLE INTUBATION VIDEO ENDOSCOPE
• Type of Device: VIDEO ENDOSCOPE
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188100
• MDR Report Key: 6921065
• MDR Text Key: 89483060
• Report Number: 1221826-2017-00084
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 11301BNX
• Device Catalogue Number: 11301BNX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• 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