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

Model Number 470056-05

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported that the 0-degree endoscope plus had a cut in the cord.There was no report of patient involvement.

Manufacturer Narrative

Based on the claim against the product by the customer noting cut in cord, 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 0-degree endoscope plus was analyzed and found to have cable integrity damage at zone c and laser markings on housing damage/markings on housing nose/shell housing.The 0-degree endoscope plus had an error 45312 in the right eye.The voltage test and vch current test failed.The endoscope had missing endoscope adapter (aea) retaining ring or screws, discolored housing, and visible light through cable jacket.This complaint is a reportable malfunction event due to the following conclusion: the xi endoscope was found with a missing camera instrument adapter (aea) component.A missing retaining ring 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: 16440336
• MDR Text Key: 310286760
• Report Number: 2955842-2023-10898
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2023

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: 470056-05
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/24/2023
• 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.