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

Model Number 470027-64

Device Problem Component Missing (2306)

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

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The endoscope involved with this complaint underwent a device evaluation. Failure analysis investigation confirmed the reported complaint. The endoscope was missing the attached endoscope adapter (aea) retaining ring or screws. A review of the submitted image was performed by the isi quality investigations engineer (qie). The qie confirmed the customer was alleging that the aea was dislodged. However, the gap between the adapter and housing is expected. A review of the log for the endoscope associated with this event was performed. Per logs, the endoscope ((b)(4)) was last used on (b)(6) 2020 on system sk0831. The endoscope had 1639 uses remaining. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Based on the information provided at this time, this complaint is being reported due to the following conclusion: a missing 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. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Field: if implanted, give date is not applicable because the product is not implantable. The information for blank fields in initial reporter is not available. Field: if remedial action initiated, check type is not applicable.

Event Description

It was reported that out of box, there was a distance between the ¿clamping device¿ and the endoscope head. The gray plastic part to lock the endoscope had too much play and did not lock itself as usual. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the initial reporter on 21-oct-2020 and obtained the following additional information: the issue occurred after unpacking the endoscope, prior to starting the procedure. There was no patient involvement.

• 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: 10789477
• MDR Text Key: 214801911
• Report Number: 2955842-2020-11165
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470027-64
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2020
• 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

Patient Treatment Data

Date Received: 11/04/2020 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES