MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TORRENT SCOPE CONNECTOR

Model Number 00711570

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records indicates no issues during manufacture; the devices were manufactured to specification.The user facility returned devices from lots 1700319, 1620223, 1619799, and 1705174.Examination found evidence of excessive tightening such as cracking on the luer of some devices.The instructions for use include the following information: "when attaching the scope connector to the port, take care to ensure that the scope connector is aligned to the port and avoid excessive tightening.Misalignment or excessive tightening of the scope connector could lead to the possibility of leakage." in-service training on use of the device has been provided to the customer.Additional lot details: lot: 1620223, exp date: 12/14/2019, udi: (b)(4); lot: 1700319, exp date: 01/08/2020, udi: (b)(4); lot: 1705174, exp date: 04/05/2020, udi: (b)(4).

Event Description

The torrent irrigation scope connector is used in conjunction with the torrent irrigation tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) and are intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit).The user facility reported sterile water spray from the torrent scope connector puddled on the floor.The event dates were unknown.There was no harm to the patient or user.

• Brand Name: TORRENT SCOPE CONNECTOR
• Type of Device: SCOPE CONNECTOR
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060
• MDR Report Key: 6609007
• MDR Text Key: 76722921
• Report Number: 1528319-2017-00017
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00816765011652
• UDI-Public: (01)00816765011652(17)191214(11)161214(10)1619799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2017

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: Physician
• Device Expiration Date: 12/14/2019
• Device Model Number: 00711570
• Device Catalogue Number: 00711570
• Device Lot Number: 1619799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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