MAUDE Adverse Event Report: TELEMED SYSTEMS INC. SCLEROTHERAPY NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number 2040LC

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Event Description

Nurse reported that during this procedure, the nurse introduced a sclerotherapy needle to the field; when it was being advanced down the endoscope, the physician noticed that the covering had become partially removed exposing the inner metal device.This product was withdrawn and a new device used.The area of concern did not reach the patient and the endoscope was not harmed.The device was saved and will be released to the company representative on wednesday.(for the convenience of the company's review) pictures will be sent separate from this report to the fda.Manufacturer response for sclerotherapy needle, sclerotherapy needle 25ga x 5mm (per site reporter): i will include the reps name prior to closing this event for final submission.The device is disposable.The device and package will be released to company rep the company is telemed.I put the package pic and the lot # and exp date into the sr.

• Brand Name: SCLEROTHERAPY NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TELEMED SYSTEMS INC.; 8 kane industrial drive; hudson MA 01749
• MDR Report Key: 6636219
• MDR Text Key: 77416446
• Report Number: 6636219
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 2040LC
• Device Lot Number: L16702040
• Other Device ID Number: 25GA X 5MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A COLONOSCOPE
• Patient Age: 83 YR