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 11/01/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the 0-degree endoscope had a piece that popped off. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the 0-degree endoscope involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/ confirmed the customer reported complaint. The endoscope had the dislodged endoscope adapter (aea) retaining ring or screws and the root cause of this failure was due to manufacturing. The endoscope had the cable integrity (visual damage) at zone b. A review of the endoscope logs associated with this event has been performed. Per logs, the endoscope (470057-08/936998) was last used on (b)(6) 2021 on system (b)(4). The endoscope had 1950 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: during failure analysis testing, the xi endoscope was found to have dislodged camera instrument adapter (aea) component with no evidence of mishandling or misuse. A dislodged camera adapter and/or 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. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.

• 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: 13102336
• MDR Text Key: 286747334
• Report Number: 2955842-2021-11826
• Device Sequence Number: 1
• Product Code: NAY
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 11/17/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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 Treatment Data

Date Received: 12/28/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES