MAUDE Adverse Event Report: MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Failure to Clean Adequately (4048)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported a biopsy forceps clip fell into a patient.It was reported the biopsy forceps clip became disconnected during the retraction of the forceps through the endoscope during the previous patient procedure.The olympus 190 series endoscope was reprocessed in their medivators dsd-201 automated endoscope reprocessor (aer).(b)(4) followed up with the nurse manager:0 she reported the physician was trying to retrieve a polyp and when they slipped the forceps down the biopsy channel, a forceps clip fell out into the patient.The physician retrieved the clip and suctioned it back up the endoscope.The nurse manager also stated that the forceps clip becoming loose is a known issue.It is unknown what product name or brand of biopsy forceps clips was used.The facility confirmed they sent their endoscope to be rebuilt by olympus.There was no report given to medivators as to the extent of damage there was to the endoscope.There was no adverse event or user harm reported.This complaint will continue to be monitored in the medivators complaint system.

Event Description

The facility reported a biopsy forceps clip fell into a patient.It was reported the biopsy forceps clip became disconnected during the retraction of the forceps through the endoscope during the previous patient procedure.The olympus 190 series endoscope was reprocessed in their medivators dsd-201 automated endoscope reprocessor (aer).

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• 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: 8307520
• MDR Text Key: 135093391
• Report Number: 2150060-2019-00012
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2008
• 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
• Treatment: OLYMPUS 190 SERIES ENDOSCOPE
• Patient Outcome(s): Other