MAUDE Adverse Event Report: MEDTRONIC XOMED INC. ENDO-SHEATH®; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number 224401

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

This device is used for therapeutic purposes.Product evaluation: analysis results not available; device not returned for evaluation.

Event Description

It was reported that the patient presented to ambulatory outpatient for consultation with an ent regarding malignant neoplasms of the language base.While using the nasoendoscope inside the patient, the tip of the endo-sheath ripped [became detached] and fell into the patient, which required withdrawal of the nasoendoscope to remove the tip.It was successfully retrieved with no report of additional procedures or patient impact.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer 09/03/2015.Date received by manufacturer: 09/08/2015.Product evaluation: for analysis; received 1 un-sealed sample; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].When compared to the assembly drawing: visually, the distal tip / window had become detached which would have resulted in the reported event.When viewed under magnification, the break point was a jagged pattern and there were many small fractures in close proximity.The proximal end to the break point measured 12¿.The tip / window was affixed to a piece of tape and was crushed which likely occurred during handling.There was no definitive evidence of improper manufacturing and therefore has been ruled out as a likely cause.The complaint was confirmed for the alleged malfunction [tip became detached].(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO-SHEATH®
• Type of Device: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4939386
• MDR Text Key: 23834782
• Report Number: 1045254-2015-00246
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K012543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2015
• Device Model Number: 224401
• Device Catalogue Number: 224401
• Device Lot Number: 0206188578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00073 YR