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

Model Number 370892-03

Device Problem Optical Distortion (3000)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci assisted surgical procedure, the zero degree endoscope had blurry image.The procedure was converted to another da vinci system.There was no reported injury.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the zero degree endoscope involved with this complaint, the customer reported complaint was confirmed.The endoscope was received with mechanical damage to distal window assembly hermetic seal resulting in fluid invasion.Additionally, mechanical damage and or deep scratches to the ocular sleeve and shaft assembly were noted.Fragments of adhesive of the distal window were missing.No image or video was available for review.A review of the 0-degree endoscope (part number 370892-03/lot number sf1550506) associated with this event has not been performed as si endoscopes would not get captured by system logs.As a result, a tool usage log could not be performed to determine when the endoscope was last used during a procedure.This complaint is reportable malfunction event due to the following: the customer converted to another da vinci system due to blurry issue with a zero degree endoscope.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.

Manufacturer Narrative

Additional information can be found in the following sections: g3, g6, h2, h6 and h10.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed there was no patient injury, and the system function was inspected after the system was started up.The issue was with the optics and not the camera.The customer corrected the initial information that had been provided and indicated the surgery was not converted to another da vinci system.The surgery was complete successfully robotically.The hospital declined to provide patient related information.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Type of Device: ENDOSCOPE
• 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: 15696507
• MDR Text Key: 306910121
• Report Number: 2955842-2022-14984
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874110201
• UDI-Public: (01)00886874110201
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K101077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 370892-03
• Device Catalogue Number: 370892
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES