MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENDOSCOPE

Model Number 470056-05

Device Problem Component Missing (2306)

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

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Image/video review: no image, or video clip for the reported event was submitted for review. Instrument log review: this endoscope was last used on (b)(6) 2020 on system sl0215 with 1939 uses remaining. Intuitive surgical, inc. (isi) received the endoscope involved with this complaint and completed the device evaluation. Failure analysis confirmed the reported issue. The camera was found to have a cut in zone b of the cable jacket. There were additional findings not reported by site. The camera was found to have several deep scratches on the housing, the retaining ring was missing from the endoscope adapter, and mechanical damage was found on the cable ferrule. Review of the error log found that the scope generated error code (b)(4). This complaint is being reported because the endoscope adapter retaining ring was missing, which could result in poor camera control leading to un-intuitive 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. The product is not implantable; it is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that after a da vinci-assisted surgical procedure, the endoscope had a tear/cut in the cord. The procedure was completed with no reported injury.

• Brand Name: DA VINCI
• 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: 10796687
• MDR Text Key: 216644283
• Report Number: 2955842-2020-11168
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191736
• 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: 10/13/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470056-05
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/13/2020
• 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