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

Model Number 470057-05

Device Problem Material Integrity Problem (2978)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting broken gray mount, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 30-degree endoscope instrument was analyzed and found to have the camera-adapter bearing broken.Additionally, the endoscope was visually inspected and found with a dislodged retaining ring.Also, the endoscope cable was visually inspected and found with defect at zone c 1/3 near the scope housing.Visual inspection confirmed visible light shining through the cable insulation jacket when the cable was plugged into the internal system or equivalent and illumination was powered on.The endoscope was visually inspected and manually tested by hand using series of movement tests and failed.The endoscope was detected with rattling or noise from the housing and/or detected loose balls from the led windows.Therefore, the endoscope was disassembled and confirmed with dislodged desiccant balls inside backend housing.The instrument had rattling in the front housing and laser marking on shell housing damage.The complaint regarding broken gray mount was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the 30-degree endoscope had a broken gray mount.The procedure was completed with no reported injury.

• 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: 17726207
• MDR Text Key: 323169959
• Report Number: 2955842-2023-18378
• 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
• Report Date: 08/17/2023

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: 470057-05
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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