MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; DOUBLE FENESTRATED GRASPER

Model Number 420189-09

Device Problem Break (1069)

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

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Upon investigation, the instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from the clevis.This complaint is being reported due to the following conclusion: the customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the instrument was "out of controlled during procedure".It was identified that the wire of the double fenestrated grasper instrument was loose and broken.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: DOUBLE FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: pat flanagan ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8216009
• MDR Text Key: 132922457
• Report Number: 2955842-2018-10801
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111581
• UDI-Public: (01)00886874111581(10)N10180105
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420189-09
• Device Lot Number: N10180105 665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1