MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. HISTOLOCK RESECTION DEVICE

Model Number	00711117
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon investigation a steris senior product manager learned the customer used the histolock resection device for cold snaring (without electrocautery), which is contrary to the instructions for use.A forceps and snare were used to free the histolock, resulting in a short procedural delay.The instructions for use for the histolock resection device states the following warning information regarding correct use of device: "endoscopic polypectomy with electrosurgical snares should not be performed without a thorough understanding of the principles of electrosurgical energy.The electrosurgical unit should be set to the proper setting per the physician's request that will allow resection with controlled hemostasis.Attach the respective olympus style active cord to the snare's diathermic handle connection prior to excision of polyps or tissue.Avoid forcefully closing the snare (as evident by sheath collapsing or crushing), without adequate electrocoagulation which can cause bleeding, incomplete cutting, or snare incarceration around the polyp." it was noted the user facility used no electrocoagulation during procedure, likely attributing to the issue.The product specialist conducted in-service with the customer and counseled on the proper use of the histolock resection device, specifically instructing the customer that the histolock is not to be used for cold snaring.No additional issues have been reported.
Event or Problem Description
The user facility reported that the histolock resection device got caught on tissue during a patient procedure.The patient procedure was successfully completed following a short delay.No report of injury.
Additional Manufacturer Narrative
Upon the return of the device the lot number has been identified (5639128).No additional issues have been reported.

• Brand Name: HISTOLOCK RESECTION DEVICE
• Common Device Name: RESECTION DEVICE
• 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: 19184365
• Report Number: 1528319-2024-00036
• Device Sequence Number: 7431665
• Product Code: FDI
• UDI-Device Identifier: 00724995182625
• UDI-Public: 00724995182625
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 04/25/2024

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: 00711117
• Device Catalogue Number: 00711117
• Device Lot Number: 5639128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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