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

Model Number	00711570
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record indicates no issues during manufacture; the devices were manufactured to specification.The user facility returned devices from lots 1705886.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.
Event or Problem 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.There was no harm to the patient or user.

• Brand Name: TORRENT SCOPE CONNECTOR
• Common Device Name: SCOPE CONNECTOR
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 6676572
• Report Number: 1528319-2017-00019
• Device Sequence Number: 19198645
• Product Code: OCX
• UDI-Device Identifier: 00816765011652
• UDI-Public: (01)00816765011652(17)200419(11)170420(10)1705886
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K103239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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
• Operator of Device: Physician
• Device Expiration Date: 04/19/2020
• Device Model Number: 00711570
• Device Catalogue Number: 00711570
• Device Lot Number: 1705886
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1