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

Model Number	430060-33
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
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 was not able to confirm/reproduce the reported complaint.The camera was placed on the in-house system and successfully passed the quality assurance procedure (qap) test.No overheating error message found.A review of the logs showed no errors.The camera passed the edt (endoscope diagnostic test).Additional observations not reported by site that was not related to the customer reported complaint: the sp camera was found to have damaged distal fibers at the distal end.Missing material approximately 0.026" x 0.033" was not returned.Root cause of this failure is attributed to user.The sp camera was found to have signs of corrosion on the bearings at the proximal end.The input bearings exhibit orange discoloration.Root cause of this failure is attributed to user.The sp camera was found to have an excessive amount of dried residue around the clamping pulley cable grooves.The sp camera was transferred to advanced failure analysis engineer (afae) for further investigation.Afae found the epoxy adhered to scope's tip, over the fiber bundle, was missing fragments.The root cause of both the residual soil and missing epoxy fiber fragment is design-related.A review of the instrument log of the single port camera (part # 430060-33 /serial # (b)(4)) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The alleged event occurred on the 11th use of the instrument.A review of the site's complaint history does not show any additional complaints for this product.No image or procedure video was provided for review.Based on the information provided at this time, this complaint is being reported due to the following: the 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 a da vinci-assisted surgical procedure, a single port (sp) camera exhibited an overheating error message.The customer used a backup sp camera instrument to complete the case.The procedure was completed with no reported injury.On 30-dec-2021, intuitive surgical, inc.(isi) has performed follow-up to request additional information, but no further details were available.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA 0 DEGREE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13285764
• Report Number: 2955842-2022-10083
• Device Sequence Number: 11998003
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: 11/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown