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

Model Number	430060-41
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sp camera instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The camera was found to have distal tip damage.A piece measuring approximately 0.128" x 0.217" in length was missing from the distal tip shell.The missing piece was not returned with the camera.For clarification, the missing piece on the sp camera tip was not covered/retained by the sheath.The failure mode is indicative of mishandling and misuse.A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event.No images or procedure video were provided for review.A review of the instrument log for the instrument associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 using system sp0109, with 16 uses remaining.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date in is not applicable.Field is not applicable because the product is not implantable.The information for blank fields in is not available.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.
Event or Problem Description
It was reported that after a da vinci-assisted laryngectomy (tracheo-esophageal puncture) surgical procedure, the sp camera had a chip at the tip.A similar backup endoscope was used to continue with the case.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) obtained the following information from the customer about the complaint: the type of da vinci-assisted surgical procedure performed was a laryngectomy (tracheo-esophageal puncture).The event date of the da vinci-assisted surgical procedure was (b)(6) 2022.The camera was inspected prior to use and then handed off field.The staff stated the camera was chipped.No photographic images of the device or a video recording of the procedure is available for isi review.No fragments fell into the patient.The procedure was completed with a back up endoscope.There was no report of patient injury.The scope never reached the patient.With regards to the questions about the patient demographics, the customer noted that the camera instrument did not reach patient.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• 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: 14497389
• Report Number: 2955842-2022-11790
• Device Sequence Number: 20283550
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 430060-41
• Device Catalogue Number: 430060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown