MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. GRAPTOR (GRASPING RETRACTOR); ENDOSCOPIC INSTRUMENT

Model Number	420278-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional 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 the instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The clevis did not exhibit any damage or wear marks.Other cables at the wrist 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 could cause or contribute to an adverse event if the malfunction were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer noted a broken cable on the grasping retractor instrument.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.
Additional Manufacturer Narrative
In relation to the reported event, intuitive surgical, inc.(isi) received voluntary report uf (b)(4) on 07/24/2017 with the following event description: while using the robotic grasping forcep, the cable broke at the tip of the instrument.The instrument was and replaced with another forceps.No harm to the patient.There were 5 lives left on the instrument.Procedure - left sided nephrectomy.Device failed (e.G.Broke, couldn't get it to work or stopped working) other than the procedure name there is no additional information provided in voluntary report uf (b)(4) than what was initially reported.Based on this information the complaint will remain reportable due to the following conclusion: the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

• Brand Name: GRAPTOR (GRASPING RETRACTOR)
• Common Device Name: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• MDR Report Key: 6737481
• Report Number: 2955842-2017-00484
• Device Sequence Number: 1490348
• Product Code: NAY
• UDI-Device Identifier: 00886874111772
• UDI-Public: (01)00886874111772(10)N10161010
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: 420278-06
• Device Lot Number: N10161010 346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1