MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number 471205-17

Device Problem Difficult to Remove (1528)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection, the instrument was stuck together in the cannula and could not be removed.The site replaced the instrument and completed the procedure as planned with no report of patient harm, adverse outcome or injury.Follow-up has been performed to request additional information related to the reported event.However, as of the date of this report, no further details have been received.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument and performed a device evaluation.Failure analysis confirmed the reported issue.The instrument was found to have the main tube broken.A piece measuring proximately 0.113¿ x 0.110¿ in size, was not returned with the instrument.As a result of the broken main tube, the instrument was returned with a cannula and a cannula seal stuck.The root cause of broken instrument main tube is typically attributed to mishandling/misuse.A review of the device logs for the fenestrated bipolar forceps (part# 471205-17 | lot-sequence# k14210906-0218) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2022 during a hysterectomy ¿ benign on system serial# (b)(4).No investigation required as no image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 14247447
• MDR Text Key: 299401745
• Report Number: 2955842-2022-11306
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K14210906
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K14210906 0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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 Age: 68 YR
• Patient Sex: Female