MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET

Model Number	00711168
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their roth net device was observed to have a "broken net".User facility personnel utilized another roth net however, the device "broke".No report of injury.
Additional Manufacturer Narrative
User facility personnel stated that the devices subject of the reported event were disposed of and cannot be returned for evaluation.Without the return of the subject devices, a root cause cannot be determined.The device history records (dhrs) were reviewed and confirmed the devices were manufactured to specification.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.No additional issues have been reported.
Additional Manufacturer Narrative
During follow-up with user facility personnel, it was determined that the roth net that was being utilized was likely too small for the removal of the peg tube internal bolster subsequently causing the reported event to occur.Steris performed in-service training on the proper use and operation of the roth net and the importance of using the appropriate size device for applicable patient procedures.A complaint review was performed and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: ROTH NET
• Common Device Name: ROTH NET
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 18505616
• Report Number: 1528319-2024-00003
• Device Sequence Number: 8145678
• Product Code: GCJ
• UDI-Device Identifier: 00724995182755
• UDI-Public: 00724995182755
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: Health Professional
• Device Model Number: 00711168
• Device Catalogue Number: 00711168
• Device Lot Number: 5807017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown