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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ENDOSCOPIC IRRIGATION PUMP
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 9288225
• Report Number: 2150060-2019-00070
• Device Sequence Number: 11340392
• Product Code: OCX
• UDI-Device Identifier: 00677964063664
• UDI-Public: 00677964063664
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other