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

Model Number 470056-08

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

It was reported that prior to starting a da vinci-assisted surgery, a 0-degree endoscope was broken.The procedure was completed with a spare endoscope with no patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: customer indicated the issue occurred on (b)(6) 2022, and it was during case set-up, before the procedure.There was no patient involvement.

Manufacturer Narrative

Based on the claim against the product by the customer noting a 0-degree endoscope was broken, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the endoscope to perform failure analysis.The 0-degree endoscope was analyzed and found to be missing the aea retaining ring.No error was found in log or at qap.The desiccant container had damage and there were loose desiccant balls.Cable damage was noted in zone c.There was artifact found in right and left eyes.The complaint regarding a 0-degree endoscope was broken was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause is attributed to the manufacturing.This complaint is being reported due to the following conclusion: failure analysis acknowledges that the 0-degree endoscope was found with a dislodged camera instrument adapter (aea) component.A dislodged camera adapter results 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.

• 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: 16419104
• MDR Text Key: 310258976
• Report Number: 2955842-2023-10808
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470056-08
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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.