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

Model Number	00711155
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8025624
• Report Number: 1528319-2018-00035
• Device Sequence Number: 1303133
• Product Code: FDI
• UDI-Device Identifier: 00816765011270
• UDI-Public: (01)00816765011270
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 00711155
• Device Catalogue Number: 00711155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1