MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

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

Patient Problem Abrasion (1689)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported while an endoscope reprocessing technician was handling the hookup used with their dsd edge automated endoscope reprocessor, he cut his finger.It was reported that the affected employee was cut underneath his finger nail from the stainless steel connector ring of the hookup.Medivators regulatory affairs followed up with the facility and it was reported that the affected employee received medical care at the employee health center.It was reported that there were no lasting effects and he is currently fine.This is an isolated incident and medivators has received no similar complaints.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported while an endoscope reprocessing technician was handling the hookup used with their dsd edge automated endoscope reprocessor, he cut his finger.The affected employee received medical care from the facility's employee health center and is reported to be fine.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7339559
• MDR Text Key: 102437276
• Report Number: 2150060-2018-00019
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

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
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other