MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; HARMONIC ACE

Model Number 480275

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

The harmonic ace curved shears instrument has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A follow-up mdr will be submitted if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video was provided by the site for review.The instrument's lot number was not provided so no log review to confirm event information could be performed.This complaint is being reported based on the following conclusion: it was reported that during a da vinci-assisted surgery, a fragment broke off the instrument and the location of the fragment is unknown.Unintended fragment(s) falling into the patient may require surgical intervention.There was no report of injury resulting from the patient retaining a foreign object, however unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the instrument breakage to occur and the location of he broken instrument piece.

Event Description

Medwatch (b)(4) was received with the following information reported from the hospital site: "during intraop robotic hysterectomy, surgeon was using a harnonic ace curved shears (lot 4 m91200415, exp date 04/30/22, ref 480275) and one of the tip prongs was broken while in use.A search for the broken part was done inside the patient and outside, but was not found, surgical manager was informed and communicated with doctor that no xray needed, as per policy.However, he has to disclose the incident to the patient to which he agreed.Intuitive was called.As per operative note: when the dissection of the vaginal cuff was performed, a small piece of the ace harmonic device was broken (distal active blade).We suspect went out to the vaginal cuff, hut we were not able to identify it.At this time, the pelvic cavity was irrigated copiously with warn saline.No active bleeding was identified.The vaginal cuff was closed in a running fashion with 0 vinc without complications.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 09-aug-2021.The reporter noted that the patient was (b)(6), rather than the previously noted 50 years of age.The instrument was inspected prior to use and there was no instrument collision reported.The instrument has not been returned to isi but is available for return.The patient has not returned to the hospital due to any post-surgical complications related to retaining a foreign object.No images or procedure video are available for review.The cause of the breakage and the location of the broken instrument piece remain unknown.

• Brand Name: DAVINCI XI
• Type of Device: HARMONIC ACE
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12317064
• MDR Text Key: 266388344
• Report Number: 2955842-2021-10928
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275
• Device Catalogue Number: 480275
• Device Lot Number: M91200415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 49 YR