MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET PLATINUM - FOOD BOLUS; RETRIEVAL DEVICE

Model Number 00711155

Device Problem Obstruction of Flow (2423)

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

Event Type  malfunction  

Manufacturer Narrative

The disposable 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 facility reported a procedure delay as a result of this event.User facility personnel reported that the patient presented with an esophageal stricture proximal to the bolus, resulting in difficulty withdrawing the device with captured bolus.User facility personnel cut the handle of the device in order to withdraw the endoscope, then successfully withdrew the device separately from the endoscope.The bolus was retrieved in the process and the procedure was completed with no harm to the patient.The lot number of the subject device is not known; however, distribution records show only two lots have been sent to the facility in question in the last 11 months.Based on this information, device history records for lots 1803430 and 1808839 were reviewed and showed that devices were made to specification.There have been no other complaints associated with either of these lots.The device subject of this event was not returned to us endoscopy for evaluation.The instructions for use include the following statements: "avoid blindly passing the roth net device past any foreign object, particularly if the entire lumen is blocked.Optimal technique using a roth net device to remove a food bolus or any foreign object will vary depending upon the type of bolus/object or clinical conditions faced during retrieval (eg.Bolus position, consistency, anatomical, or disease issues such as strictures, bolus-induced ulcerations, etc.)." the user facility accepted offer of in-service training, which was completed on 10/23/2018.

Event Description

The user facility reported the roth net device became obstructed by an esophageal stricture during a food bolus removal procedure, preventing the device withdrawal and resulting in a procedural delay.The procedure was completed with no reported harm to the user or patient.

• Brand Name: ROTH NET PLATINUM - FOOD BOLUS
• 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 rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 8025624
• MDR Text Key: 127246585
• Report Number: 1528319-2018-00035
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765011270
• UDI-Public: (01)00816765011270
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711155
• Device Catalogue Number: 00711155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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