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

Model Number 420205-16

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

An rma has been issued requesting to have the fenestrated bipolar forceps returned; however, isi has not received the rma to confirm/identify any reportable failure mode(s).A follow-up mdr will be submitted if additional information is received.A review of the instrument log for the fenestrated bipolar forceps (part# 420205-16/lot# n10190819 215) associated with this event has been performed.Per logs, the fenestrated bipolar forceps was last used on (b)(6) 2020 on system (b)(4) with 2 uses remaining.This date is prior to the reported event date provided by the customer.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is being reported due to the following conclusion: the site alleged that part of the jaw on the fenestrated bipolar forceps broke off and fell inside the patient during a da vinci-assisted surgical procedure.The piece was retrieved in the same procedure, and no additional surgical intervention was required.At this time, it is unknown what caused the breakage to occur and the piece to fall inside the patient.Although there was no reported injury and the piece was retrieved during the same procedure, fragments falling inside the patient may require surgical intervention.While there was no patient harm or injury, the reported failure mode could potentially cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted total benign hysterectomy procedure, a part of the jaw on the fenestrated bipolar forceps fell off and allegedly fell inside the patient.The piece was retrieved in the same procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) has made several attempts to follow-up with the site to obtain additional information regarding this event.However, no further details have been received as of the date of this report.

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.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11215056
• MDR Text Key: 242401854
• Report Number: 2955842-2021-10077
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10190819
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: N10190819 215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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.