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

Model Number 470056-05

Device Problem Defective Component (2292)

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

Event Date 12/09/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci assisted surgical procedure, the endoscope plus 0 degree was observed with mechanical damage.The procedure was completed with the same endoscope with no report of patient harm, adverse outcome or injury.The customer provided the following information regarding the complaint: the endoscope was difficult to barely move over console.The horizon did not match, monitor image and the horizon display.The operation was delayed 45 minutes due to the reported issue.The procedure was completed with the same endoscope with no report of patient harm, adverse outcome or injury.

Manufacturer Narrative

It was reported that during a da vinci assisted surgical procedure, the endoscope plus 0 degree was observed with mechanical damage.Based on the claim against the product by the customer noting endoscope damage, 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 endoscope instrument was analyzed and found to have difficulty moving, horizon not matching, and monitor image issues.The probable root cause of a dislodged identification board is attributed to manufacturing.This complaint is considered a reportable event due to the following conclusion: due to the reported endoscope issue, the procedure was delayed 45 minutes.

• 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: 16166145
• MDR Text Key: 308844910
• Report Number: 2955842-2022-16386
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K191736
• 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
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470056-05
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2023
• Date Manufacturer Received: 12/14/2022
• 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