MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP-UP FENESTRATED GRASPER

Model Number 470347-09

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

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

Event Date 01/17/2018

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 in the clevis.Missing crimp was approximately 0.046" x 0.032".The clevis did not exhibit any damage or wear marks.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 a 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 prior to the start of a da vinci-assisted surgical procedure, the tip-up fenestrated grasper instrument was ¿broken¿.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.There were no reports of any fragment(s) falling inside the patient.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• 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: 7321163
• MDR Text Key: 101989287
• Report Number: 2955842-2018-10044
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10170522
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470347-09
• Device Lot Number: N10170522 0119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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