MAUDE Adverse Event Report: DORNOCH TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE; WASHER OF BODY WASTE RECEPTACLES

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the dump mechanism was not working and that the 300 degree riser had plastic debris preventing it from lowering.The dump mechanism was replaced and the debris was removed resolving the reported issue.Through follow up it was found that there was debris present in both cylinders causing the 300 degree riser to remain stuck.The debris was cleaned from both cylinders and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

It was reported that during cleaning the right side is not functioning properly.Cart had debris in the cylinder causing inaccurate readings.This occurred in both cylinders.There was no harm and no delay.No adverse events were reported as a result of this malfunction.

• Brand Name: TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11854678
• MDR Text Key: 257541703
• Report Number: 0001954182-2021-00030
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TPSS100
• Device Lot Number: 0040538
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1