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

Model Number 470049-06

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure, video, or image was submitted to isi for review, and no additional technical analysis was conducted.System log investigation: a review of the instrument log for the cadiere forceps instrument lot# n10200309 / sequence 0097 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2020 on system sk0462.The instrument has 6 remaining usable lives with no subsequent use recorded.This complaint is a reportable malfunction event due to the following: the cadiere forceps instruments are multiple-use endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system.The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure.It was reported that during central processing, the cadiere forceps instrument was found to have a cable popping out.There was no report of patient involvement.Evaluation by failure analysis identified that the pitch cable was broken at the distal end of the instrument with no evidence of user mishandling or misuse.While there was no harm or injury to the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.This instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 6 remaining usable lives, therefore, had not expired.The product is not implantable.

Event Description

It was reported that during central processing, the cadiere forceps instrument was found to have a cable popping out.There was no report of patient involvement.

• 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: 10834249
• MDR Text Key: 218270910
• Report Number: 2955842-2020-11193
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112250
• UDI-Public: (01)00886874112250(10)N10200309
• Combination Product (y/n): N
• PMA/PMN Number: K150284
• 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
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470049-06
• Device Catalogue Number: 470049
• Device Lot Number: N10200309 0097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• 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