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

Model Number 470057-08

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 30-degree endoscope involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/ confirmed the customer reported complaint.The endoscope had a damaged endoscope adapter (aea) or friction issue.The root cause of the reported issue was determined to be due to mishandling/misuse.A review of the endoscope logs associated with this event has been performed.Per logs, the endoscope (470057-08/10023402) was last used on (b)(6) 2022 during a benign hysterectomy performed on system (b)(4).The endoscope had 1988 uses remaining after the last procedural use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video was provided for review.This complaint is being reported due to the following conclusion: it was reported that the console controls were "mixed up" when the camera was rotated.During failure analysis testing, the xi endoscope was found to have damaged camera instrument adapter (aea) component.A damaged 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.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the endoscope had a clicking sound and non-intuitive motion.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter, but no further information was available.

• 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: 13750563
• MDR Text Key: 296881796
• Report Number: 2955842-2022-10589
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/11/2022

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: 470057-08
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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
• Patient Sex: Female