MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD C8I OCT INTEGRATED SYSTEM; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	100106211
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
The doc holster came off of table clamp and the washers inside shorted out the circuit causing the plastic to melt.No patient was involved in this event and no adverse consequences occurred.
Additional Manufacturer Narrative
No component was returned for analysis.The device history record was not reviewed as a manufacturing/design issue is not suspected as the device was manufactured in 2016.Therefore, it has exceeded its design service life expectancy of two years per.There are no suspected manufacturing/design/ncmr/capa related issues to reference as a root cause could not be determined.Due to limited information received, root cause of the reported event could not be determined.If additional information or the unit is received, the device investigation will be updated accordingly.

• Brand Name: C8I OCT INTEGRATED SYSTEM
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 10616201
• Report Number: 3009600098-2020-00024
• Device Sequence Number: 3003713
• Product Code: NQQ
• UDI-Device Identifier: 00183739000937
• UDI-Public: 00183739000937
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K188320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2020

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
• Device Model Number: 100106211
• Device Catalogue Number: C408652
• Device Lot Number: 4786872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 12/10/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/10/2020; 12/20/2020
• 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