MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number 470400-10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted sacrocolpopexy surgical procedure, the long bipolar grasper instrument tip broke and fell into the patient.The technical service engineer (tse) reviewed the system logs and found no system related errors.The tse recommended that the image showed that the instrument tip was missing the piece and this could be discovered by x-ray.The customer confirmed that broken pieces of the instrument were found and retrieved.The procedure was completing as planned with no reported injury.The long bipolar grasper is a multiple-use electrosurgical endoscopic instrument with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).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 8mm long bipolar grasper instrument associated with this complaint and completed the device investigation.Failure analysis (fa) replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the broken grip tips to be related to the customer reported complaint.The long bipolar grasper instrument was found to have a broken grip at the midpoint of grip and a piece approximately 0.115" x 0.305" was found to be broken off.The broken piece was returned.The root cause of the broken instrument grips -tips is typically attributed to mishandling /misuse, such as excess force applied to the instrument jaws.A review of the instrument log for the long bipolar grasper instrument (470400-10/n10200317-0050) associated with this event has been performed.Per logs, the long bipolar grasper instrument was last used in a procedure on (b)(6) 2022 via system (b)(4).The alleged instrument had 3 uses remaining after the last procedural use.An event verification confirmed the procedure was performed on the reported event date.A review of the site's complaint history found that there were no other complaints for this product.Isi received images of a broken long bipolar grasper instrument.A review of the image was conducted by an isi regulatory post market surveillance (rpms) and found the following information: the review of the provided image is consistent with the customer reported complaint.The tip of the long bipolar grasper instrument was found to be broken.This complaint is being classified as a reportable adverse and malfunction event due to the following conclusion: it was alleged that the long bipolar grasper instrument broke and fragments fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure with no patient injury.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 as unintended fragment(s) falling into the patient may require surgical intervention.Follow-up was attempted, but the missing 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.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: BIPOLAR GRASPER, LONG
• 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: 14247695
• MDR Text Key: 290449829
• Report Number: 2955842-2022-11320
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10200317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150837
• 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,Followup
• Report Date: 03/29/2022

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: 470400-10
• Device Catalogue Number: 470400
• Device Lot Number: N10200317 0050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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