MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number 470026-62

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the zero degree endoscope instrument and performed a device evaluation.The customer reported complaint was confirmed but not replicated.Failure analysis discovered that the attached endoscope adapter (aea) retaining ring and screws were missing.Severe damage was found on the cable jacket.Also, errors 45310, 48216, 48221, 45314, 48217, 48225, and 48229 were found in the log.A review of the site's complaint history does not show any additional complaints related to this product.No images or videos were shared for the event.A review of the system logs revealed that the endoscope was last used successfully on (b)(6) 2020.The endoscope was not used on the event date of (b)(6) 2020 which supports the report that the issue was identified prior to the start of the procedure.This complaint is being reported because a dislodged camera adapter could result in poor camera control, which could result in unintuitive motion and subsequent tissue damage.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that prior to starting da vinci-assisted prostatectomy surgical procedure, the customer observed degraded image quality and the system reflected an error message.There was no report of patient involvement.The procedure was completed with no reported injury, harm or adverse outcome to the patient.

• Brand Name: NONE
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10631986
• MDR Text Key: 245069239
• Report Number: 2955842-2020-11042
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K171426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470026-62
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1