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

Model Number 470057-08

Device Problem Defective Device (2588)

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

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting the broken endoscope, an investigation is in progress.Intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint on which to perform a failure analysis investigation.Failure analysis is in progress.Additional information is being gathered to determine the contribution of the device to the customer reported issue.This event is being reported based on the following conclusion: the customer converted to open surgery after the start of a surgical procedure due to issues with the endoscope device.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the plastic gear on the endoscope head broke intraoperatively.The endoscope worked properly for approximately 45 minutes of the procedure before seizing up.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was converted to open surgery.The issue was not resolved with the backup endoscope.The procedure was converted because of the endoscope issue.The yellow plastic gear on the endoscope head broke during the procedure.Troubleshooting was done using a backup endoscope, but it was not working as expected and they were unsure what the issue was with the backup endoscope.There was no physical damage to the backup endoscope.The backup endoscope was used for further procedures with no issues noted.The backup endoscope will not be returned as it works well.The procedure was converted to open surgery.No issues with the reported endoscope were noted during the system's setup.The reported endoscope did work for some time.There was no reported patient complication during or after the open surgery.The video recording of the procedure was not available for review.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the 30-degree endoscope plus unit involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The 30-degree endoscope plus was found to have a bearing friction issue.The button bezel had mechanical damage as well.The complaint regarding a broken endoscope was confirmed based on the failure analysis investigation, which indicated that the device did contribute to the customer-reported issue.The failure is attributed to a component failure.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 16573238
• MDR Text Key: 311596701
• Report Number: 2955842-2023-11392
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470057-08
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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.