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

Model Number	00715050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The device subject of this complaint has not been returned to steris endoscopy for evaluation.Images of the detached loop were provided; however, without a returned device the root cause could not be determined.Statements from the instructions for use include: "continuous gentle traction should be applied on the handle to keep the roth net device closed.The following conditions may cause the device to function improperly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position, and actuating the device when the handle is at an acute angle in relation to the catheter." the distributor has offered in-service training to the user facility on behalf of steris endoscopy and the facility has accepted.No further issues have been reported.
Event or Problem Description
The distributor reported that the wire loop component of a roth net platinum retriever - universal device detached during a patient procedure in the colon.The wire loop was retrieved, the procedure was completed, and no harm to the patient or user was reported.

• Brand Name: ROTH NET PLATINUM RETRIEVER - UNIVERSAL
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10621313
• Report Number: 1528319-2020-00034
• Device Sequence Number: 14204262
• Product Code: FDI
• UDI-Device Identifier: 00724995182908
• UDI-Public: (01)00724995182908
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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 Expiration Date: 11/17/2022
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1915534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1