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

Model Number 470057-05

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the endoscope cable insulation from a 30-degree endoscope plus was broken.The procedure was being completed as planned with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "cable insulation was broken".The endoscope was found to have severe damage in zone c of the cable jacket.The aea retaining ring or screws were found missing, the camera adapter was dislodged.There were also observations of scope-bearing friction issues, mechanical damage to buttons and discoloration of housing.Advanced technical review: based on image attached to rma appears primary fa technician observed a missing screw.Since primary fa investigation text did not specify if finding was for a missing aea retaining ring or screw, the rma was escalated to a failure analysis engineer (fae) for further review.The fae reviewed attached images in rma and confirmed one screw was missing and aea is still intact with the endoscope's housing.Fae stated unintuitive motion is not an expected symptom for this observed failure (screw missing).

• Brand Name: NONE
• Type of Device: ENDOSCOPE PLUS
• 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: 17039759
• MDR Text Key: 316340442
• Report Number: 2955842-2023-15430
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470057-05
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2022
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female