MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC UTAH LOOP; GYNECOLOGICAL LOOP

Model Number	LETZ Electrode
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is reporting this event because utmd received medwatch report number mw5118217 from a medical facility.The loop electrode is a passive element of an electrosurgical circuit.Due to the anonymity of the medwatch report, no other information is available for further investigation and analysis.
Event or Problem Description
On (b)(6) 2023 utmd received a medwatch report number mw5118217 with the event description "during leep procedure, equipment failed cutting and cauterizing after incision resulting in injury to pt".

• Brand Name: UTAH LOOP
• Common Device Name: GYNECOLOGICAL LOOP
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC; 7043 south 300 west; midvale 84047
• Manufacturer (Section G): UTAH MEDICAL PRODUCTS, INC; 7043 south 300 west; midvale UT 84047
• Manufacturer Contact: ben shirley ; 7043 south 300 west; midvale, UT 84047 ; 8015661200
• MDR Report Key: 17316623
• Report Number: 1718873-2023-00002
• Device Sequence Number: 19832449
• Product Code: HGI
• UDI-Device Identifier: H671DLPE110
• UDI-Public: H671DLPE110
• Combination Product (Y/N): N
• PMA/510(K) Number: K905263
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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?: No
• Device Model Number: LETZ Electrode
• Device Catalogue Number: DLP-E11
• Device Lot Number: 1222547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown