MAUDE Adverse Event Report: SANTA BARBARA IMAGING SYSTEMS, INC. TRINITY; 4K CAMERA HEAD 3 CMOS - EYECUP

Model Number	81-10-4100
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial complaint form received from distributor reported there were unspecified "imaging problems / connection problems".Subsequent information received from distributor indicated change of procedural technique from laparoscopic to an open procedure.Manufacturer's evaluation of the returned device indicated no faults were found.It is unknown whether the reported device caused or contributed to the issue reported.
Event or Problem Description
Imaging problems / connection problems.

• Brand Name: TRINITY
• Common Device Name: 4K CAMERA HEAD 3 CMOS - EYECUP
• Manufacturer (Section D): SANTA BARBARA IMAGING SYSTEMS, INC.; 340 storke road; suite 101; goleta CA 93117
• MDR Report Key: 8870115
• Report Number: 3011373951-2019-00001
• Device Sequence Number: 10840693
• Product Code: GCJ
• UDI-Device Identifier: 00853460007146
• UDI-Public: (01)00853460007146(11)181201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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
• Device Model Number: 81-10-4100
• Device Catalogue Number: 81-10-4100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 08/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 70