MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. HISTOGUIDE WIRE-GUIDED FORCEPS

Model Number	00711660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this event was not retained by the user facility for evaluation.Without a returned device, the cause of the problem could not be determined.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "caution: use only enough pressure to bite the tissue.Over-exertion could cause forceps to become misaligned or to fail.Note: reduce the angulation of the endoscope or lower the forceps elevator in the endoscope if resistance is felt." the facility has accepted the distributor offer of in-service training.No further issues have been reported.
Event or Problem Description
The distributor reported that the histoguide wire-guided forceps could not be pulled past the elevator of a side-viewing endoscope preventing device withdrawal through the endoscope channel, and necessitating withdrawal of the endoscope from the patient.No harm to the patient or user was reported as a result of this event.

• Brand Name: HISTOGUIDE WIRE-GUIDED FORCEPS
• Common Device Name: WIRE-GUIDED FORCEPS
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10101286
• Report Number: 1528319-2020-00015
• Device Sequence Number: 19742046
• Product Code: PTS
• UDI-Device Identifier: 00816765014295
• UDI-Public: (01)00816765014295
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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 Expiration Date: 08/05/2022
• Device Model Number: 00711660
• Device Catalogue Number: 00711660
• Device Lot Number: 1910795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1