MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SMALL GRASPING RETRACTOR

Model Number 470318-08

Device Problem Break (1069)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the small grasping retractor instrument associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue ¿ wires broken.The instrument was found to have broken pitch cables at the distal clevis hub.The broken cable segments that contain the crimps were still installed in the clevis.This instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a wire on a small grasping retractor instrument was identified to be broken.The procedure was completed with a backup instrument and there was no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: SMALL GRASPING RETRACTOR
• 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: 8203055
• MDR Text Key: 132372081
• Report Number: 2955842-2018-10789
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112441
• UDI-Public: (01)00886874112441(10)N10180328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470318-08
• Device Lot Number: N10180328 0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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