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

Model Number 470049-07

Device Problem Break (1069)

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

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

An rma has been issued requesting to have the cadiere forceps instrument 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 cadiere forceps (part#470049-07/lot#n10200907 0004) associated with this event was performed.Per logs, the cadiere forceps was last used on (b)(6) 2020, on system (b)(4).The alleged event occurred on the 4th use of the instrument.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 clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: the cadiere forceps was found to have a frayed cable, and a bit of the cable reportedly fell inside the patient during a da vinci-assisted surgical procedure.The cable 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 for the cable to fall inside the patient.Although there was no reported injury and the cable 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 pancreatectomy procedure, the cadiere forceps instrument was found to have a frayed cable.The reporter indicated a bit of the cable fell into the patient and was retrieved in the same procedure.A similar backup instrument was used to proceed with the case.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.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

61, 12- intuitive surgical, inc.(isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported complaint "a bit broke".Failure analysis found the primary failure of broken grip tips to be related to the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.218" x 0.630" was found to be broken off.The broken piece was not returned.Root cause of this failure is attributed to mishandling.Failure analysis found the secondary failure of frayed grip cable to be related to the customer reported complaint.The instrument was found to have a frayed grip cable at the distal idler pulley.The frayed cable strands stuck out at the wrist.Root cause of this failure is attributed to a component failure.

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
• Type of Device: CADIERE 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: 11102079
• MDR Text Key: 235041274
• Report Number: 2955842-2020-11432
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112250
• UDI-Public: (01)00886874112250(10)N10200907
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470049-07
• Device Catalogue Number: 470049
• Device Lot Number: N10200907 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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.