MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET - FOREIGN BODY - STANDARD; RETRIEVAL DEVICE

Model Number 00711052

Device Problems Bent (1059); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

The roth net retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.The user reported that when attempting to deploy the net, resistance was felt and the wire in the handle bent.The procedure was completed using a different device with no harm to the patient or user.The device history record was reviewed and no anomalies were identified.The device was not returned to us endoscopy for evaluation.On january 3, 2017 us endoscopy received medwatch report # (b)(4) consistent with the original user report.The user was contacted and confirmed that there was no harm to the patient or user.This report is made in response to the medwatch report.

Event Description

The roth net retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.The user reported that when attempting to deploy the net, resistance was felt and the wire in the handle bent.The procedure was completed using a different device with no harm to the patient or user.

• Brand Name: ROTH NET - FOREIGN BODY - STANDARD
• Type of Device: RETRIEVAL DEVICE
• 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 road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 6267613
• MDR Text Key: 65781503
• Report Number: 1528319-2017-00001
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: 00711052
• Device Catalogue Number: 00711052
• Device Lot Number: 1604716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 73