MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A6.0P8

Device Problems Device Stops Intermittently (1599); Positioning Problem (3009)

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

Event Date 12/01/2014

Event Type  malfunction  

Event Description

This complaint was initially reported to intuitive surgical, inc.(isi) for an unrelated problem associated with the customer reporting they were having continued intermittent instrument engagement problems with one of the patient side manipulators (psm).The psm is an instrument arm located on the patient side cart that provides the sterile interface for the endowrist instruments.The psm was replaced.There was no report of patient involvement or adverse outcomes.

Manufacturer Narrative

The patient side manipulator (psm) arm was returned to intuitive surgical, inc.(isi) for evaluation.Failure analysis investigation found the psm failed the weighted brake drop test.This complaint is being reported due to the patient side manipulator arm failing the weighted brake drop test during failure analysis.No patient involvement occurred, however, if this malfunction were to recur it could likely cause or contribute to an adverse event.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• 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: 4355284
• MDR Text Key: 5222408
• Report Number: 2955842-2014-05909
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A6.0P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2955842-020312-001C
• Patient Sequence Number: 1