MAUDE Adverse Event Report: PARKS MEDICAL ELECTRONICS, INC. 8.3MHZ PENCIL PROBE 7 FOOT ODU CONNECTOR; TRANSDUCER, ULTRASONIC

Model Number	832-1831-01
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Issue with parks medical doppler usage in or/surgical settings.Manufacturer details: manufacturer: parks medical electronics, inc.Products: gudid: (b)(4) - 8.3mhz pencil probe, 7 foot odu connector, date of manufacture: 2022-05-23, gudid: (b)(4) - 8.1mhz pencil probe, 7 foot odu connector.Problem description: parks medical doppler devices, specifically the 8.3mhz and 8.1mhz pencil probes, have been utilized in or/surgical settings considered to be wet locations.These devices are fda-approved as class ii devices, which stipulates they are intended for external use only on the skin and not for intraoperative use during surgeries.Key issues identified: inappropriate use: despite being approved only for external use, parks medical representatives have been supporting the intraoperative use of these doppler devices, contrary to fda regulations and their own instructions for use (ifu) manual.Contradictory documentation: the ifu [instructions for use] specifically states that the dopplers are for external use on the skin.Nonetheless, parks medical has provided a document that contradicts this, endorsing the intraoperative use of these devices.Lack of cleaning instructions: the ifu does not include adequate cleaning instructions for removing bioburdens from the probe, nor does it mention approved cleaning agents.This omission poses a potential risk for increased infections due to improper sterilization.Unresponsive manufacturer: multiple attempts to contact parks medical for clarification on these contradictions and for guidance on cleaning procedures have been unsuccessful.The company has not addressed the inconsistencies between the fda approval, the ifu, and their support for intraoperative use without adequate cleaning protocols.Potential implications: regulatory non-compliance: using the doppler devices intraoperatively goes against fda class ii approval, leading to regulatory non-compliance.Increased infection risk: the lack of proper cleaning instructions in the ifu increases the risk of infections due to bioburdens on the probe.Summary the use of parks medical electronics' doppler devices in operation room/surgical settings is problematic due to misalignment with fda class ii approval and inadequate cleaning instructions in the ifu.The manufacturer's endorsement of intraoperative use, despite their fda classification and lack of response to inquiries, raises significant safety and regulatory concerns.Action needed: this issue requires immediate attention to halt the misuse of these doppler devices in surgical settings and to seek definitive guidance from parks medical regarding cleaning protocols and proper use in compliance with fda regulations.Manufacturer response for transducer, ultrasonic, 8.1mhz pencil probe 7 foot odu connector (per site reporter).Provided letter saying doppler is approved to be used intraoperatively.Manufacturer response for transducer, ultrasonic, 8.3mhz pencil probe 7 foot odu connector (per site reporter).They provided letter contradicting the instructions for use and fda class ii approval.

• Brand Name: 8.3MHZ PENCIL PROBE 7 FOOT ODU CONNECTOR
• Common Device Name: TRANSDUCER, ULTRASONIC
• Manufacturer (Section D): PARKS MEDICAL ELECTRONICS, INC.; 19460 sw shaw st; aloha OR 97007
• MDR Report Key: 22318343
• Report Number: 22318343
• Device Sequence Number: 11941806
• Product Code: JOP
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/30/2025
• Report Date (Section F): 05/30/2025

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
• Device Model Number: 832-1831-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/30/2025