MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM SMALL GRASPING RETRACTOR; ENDOSCOPIC INSTRUMENT

Model Number 470318-08

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

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

Event Date 01/10/2018

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.For clarification, the instrument was found to have a broken pitch cable at the distal clevis hub.Motion was no longer intuitive at the wrist.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.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 suggests that if the malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the tip of the small grasping retractor instrument was not holding.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: 8 MM SMALL GRASPING 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: 7276843
• MDR Text Key: 100467886
• Report Number: 2955842-2018-00102
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112441
• UDI-Public: (01)00886874112441(10)N10170502
• 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: 01/29/2018

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: 470318-08
• Device Lot Number: N10170502 0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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