MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA 0 DEGREE

Model Number	430060-33
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the single port (sp) camera instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the reported complaint.The sp camera instrument was found to have residual soil on the distal tip fibers.A piece of the epoxy measuring approximately 0.032¿ x 0.056¿ was missing from the distal tip.The sp camera instrument had 4 uses remaining.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.An instrument/accessory log review was conducted, which resulted in the following findings: the logs show the customer last used the sp camera instrument on (b)(6) 2019 with system (b)(4).The camera had 4 lives remaining.This last usage of the device was before the reported event date, indicating that the device did not pass recognition or the issue was identified before installation on the reported event date.A system log review cannot be performed because the system logs are not available at this time.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following: the endowrist sp camera was found to have a piece of epoxy layer missing over the distal end fibers and it is unknown whether epoxy fragments may have fallen inside a patient.While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.
Event or Problem Description
It was reported that, during central processing, the customer noted ¿bioburden baked onto scope.¿ there was no report of patient involvement.Intuitive surgical, inc.(isi) attempted to follow up with the reporter and obtained the following additional information: the reporter no longer works for the hospital.No additional information was available.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA 0 DEGREE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11160518
• Report Number: 2955842-2021-10032
• Device Sequence Number: 19813469
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: 430060-33
• Device Catalogue Number: 430060
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2019-08-R
• Patient Sequence Number: 1