MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOSHIELD IRRIGATOR; BIOPSY VALVE

Model Number 711133

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

The device covers the opening of the biopsy channel of an endoscope and provides access for device passage, exchange and irrigation.The company received a complaint that during 2 procedures fluid sprayed from the biopsy cap onto the doctor.It was reported that the physician sought medical attention (blood work).As of the date of this mdr, there has been no reported harm to the doctor, nurse or patient.

Manufacturer Narrative

The actual device involved was not returned for investigation.Therefore, the exact root cause of the leakage could not be determined.There has been no reported injury to either patient or user, although the physician did seek medical attention (blood work).Osha 1910.1030 (d) (3) (i) and asge technical guidelines requires the facility to provide, and wear, appropriate protective equipment.

• Brand Name: BIOSHIELD IRRIGATOR
• Type of Device: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd.; mentor OH 44060
• Manufacturer Contact: carroll martin ; 5976 heisley rd.; mentor, OH 44060 ; 4406394494
• MDR Report Key: 3834983
• MDR Text Key: 4412301
• Report Number: 1528319-2014-00005
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2014

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 Expiration Date: 09/30/2016
• Device Model Number: 711133
• Device Catalogue Number: 711133
• Device Lot Number: 1324699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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