MAUDE Adverse Event Report: INTUITIVE SURGICAL INC ENDOWRIST; CADIERE FORCEPS

Model Number 470049-04

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

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

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed that the instrument does not turn on when connected.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 and the clevis did not exhibit any damage or wear marks.The other cables at the wrist of the instrument were not damaged.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.The customer reported complaint does not itself constitute an mdr reportable event; however; the broken pitch cable found during failure analysis evaluation could cause or contribute to an adverse event if the failure mode were to recur.

Event Description

It was reported that during a da vinci assisted surgical procedure, the cadiere forceps instrument would not "turn on when connected." there were no reports of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST
• Type of Device: CADIERE FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL INC; 1020 kifer road; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL INC; 1020 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 1020 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7282909
• MDR Text Key: 100666437
• Report Number: 2955842-2018-10005
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112250
• UDI-Public: (01)00886874112250(10)N10170801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470049-04
• Device Lot Number: N10170801 0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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