MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TENACULUM FORCEPS

Model Number 470207-08

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

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

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

The instrument was returned to intuitive surgical, inc.(isi) and evaluated.Failure analysis confirmed the customer reported complaint of a ¿broken cable¿.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.A device history record (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 in central processing, a broken cable was identified on the tenaculum forceps instrument.There was no report of a patient injury.

• Brand Name: ENDOWRIST
• Type of Device: TENACULUM FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7626685
• MDR Text Key: 112502102
• Report Number: 2955842-2018-10310
• Device Sequence Number: 1
• Product Code: NAY
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

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: 470207-08
• Device Lot Number: N101705090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• 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