MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. LARGE NEEDLE DRIVER; ENDOSCOPIC INSTRUMENT

Model Number 420006-08

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 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 missing from clevis in the clevis.The clevis did not exhibit any damage or wear marks.Other cables at the wrist were not damaged.Device history record (dhr) review-dhr review for the device(s) involved with the reported event has been completed.No non-conformances were identified to be related to this complaint.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer found that the large needle driver instrument had metal cables breaking at the wrist.There was no report of fragments falling into the patient.The procedure was completed with no patient harm, adverse outcome or injury.

• Brand Name: LARGE NEEDLE DRIVER
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6875751
• MDR Text Key: 86609025
• Report Number: 2955842-2017-00614
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111192
• UDI-Public: (01)00886874111192(10)N10170213
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2017

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: 420006-08
• Device Lot Number: N10170213 069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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