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

Model Number 420204-05

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

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

Event Date 12/13/2017

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 the clevis. The crimp measures approximately 0. 032 x 0. 046. Other cables at the wrist were not damaged. A device history record review (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument. 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 failure mode were to recur.

Event Description

It was reported that during set up for a da vinci-assisted surgical procedure, while connecting physical damage was observed on the atrial retractor instrument. The planned procedure was completed and no patient harm, adverse outcome, or injury was reported. There were no reports of any fragment(s) falling into the patient. Intuitive surgical, inc. Has made multiple follow-up attempts for additional information. However, no additional information has been received as of date of this report.

• Brand Name: ATRIAL RETRACTOR
• 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: 7227881
• MDR Text Key: 98733891
• Report Number: 2955842-2018-00065
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 420204-05
• Device Lot Number: S10110127 661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse