MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. GRASPING RETRACTOR INSTRUMENT; ENDOSCOPIC INSTRUMENT

Model Number 420278-04

Device Problem Malposition of Device (2616)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

It was reported that prior to starting a da vinci surgical procedure, cables were exposed at the distal end of the grasping retractor instrument.Nothing reportedly fell into a patient and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis found both pitch cables loose at the wrist.The clevis did not exhibit any damage or wear marks.Both cable crimps remained in the clevis.Additionally, one of the loose pitch cables had become frayed.The frayed segment stuck out at the instrument's wrist.Upon removing the housing, the pitch cables were at clamping pulley.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however; the frayed cable, found during failure analysis evaluation could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: GRASPING RETRACTOR INSTRUMENT
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3725760
• MDR Text Key: 4278035
• Report Number: 2955842-2014-01958
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420278-04
• Device Lot Number: M10130909 731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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