MAUDE Adverse Event Report: MEDIVATORS ENDO STRATUS IRRIGATION PUMP; ENDOSCOPIC IRRIGATION PUMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported their endo stratus irrigation pump was irrigating harder than normal during a procedure and caused a patient to bleed.After several attempts mediators ra has not been able to contact the facility to confirm details of this reported event.The irrigation pump was returned to mediators for additional inspection and functionality tests by mediators depot service department.The unit performed to specification.The endostratus irrigation pump is to be used by a trained user who is responsible for using clinical judgement to set the flow rate from the pump to a suitable level to for each individual patient.The flow rate should always be set at the lowest setting at the start of a procedure as instructed in the endostratus irrigation pump user manual.There have been no details on what settings were used during the procedure.There have been no reports on the patient condition or if the patient had sought additional medical attention following their procedure.This will continue being monitored in the mediators complaint handling system.

Event Description

A facility reported their endo stratus irrigation pump was irrigating harder than normal during a procedure and caused a patient to bleed.

• Brand Name: ENDO STRATUS IRRIGATION PUMP
• Type of Device: ENDOSCOPIC IRRIGATION PUMP
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 9288225
• MDR Text Key: 165588026
• Report Number: 2150060-2019-00070
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00677964063664
• UDI-Public: 00677964063664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other