MAUDE Adverse Event Report: DEPUY MITEK LLC US IMAGE MANAGEMENT SYSTEM; ENDOSCOPIC VIDEO IMAGE PROCESSOR

Model Number Evo4K220

Device Problems Image Display Error/Artifact (1304); Intermittent Communication Failure (4038)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Pro code & common device name: unavailable/not found in furls d/b.Model#: evo4k-0119-064c.Gtin: (b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation summary: the complaint device was received at the service center.This unit was not for human use, therefore, due to cross contamination concerns this device will not be evaluate and will be placed in quarantine.Since it was not evaluated, this complaint cannot be confirmed.As the reported problem was not confirmed, a root cause for the issue that was experienced cannot be determined.A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.A review of the device history record.Device history lot a manufacturing record evaluation was performed for the finished device [evo4k-0119-064c] number, and no non-conformances were identified.Device history batch null, device history review null.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

As reported per the customer vie email, the evo 4k system was working at the olc on the friday using a single sdi input.On saturday after booting up the tower they received an error ¿no video input.This was in a cadaveric setting therefore there is no patient involvement.This is all the information the customer has at this time.This complaint is for one (1) image management system this report is 1 of 1 for (b)(4).

• Brand Name: IMAGE MANAGEMENT SYSTEM
• Type of Device: ENDOSCOPIC VIDEO IMAGE PROCESSOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9210147
• MDR Text Key: 208374487
• Report Number: 1221934-2019-59094
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 00817613020543
• UDI-Public: (01)00817613020543
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Evo4K220
• Device Catalogue Number: 242326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1