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 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The instrument was found 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¿.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 could cause or contribute to an adverse event if the failure mode were to recur.

Event Description

The tip-up fenestrated grasper instrument was returned to intuitive surgical, inc.(isi) without a reported failure.Isi followed up with the initial reporter and confirmed that the procedure was completed successfully and no fragments fell inside the patient.However, the reporter was not able to confirm what the reported issue was.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7636100
• MDR Text Key: 112712070
• Report Number: 2955842-2018-10317
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10171102
• 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: 06/19/2018

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: 470347-09
• Device Lot Number: N10171102 0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1