MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MEGA SUTURECUT NEEDLE DRIVER; ENDOSCOPIC INSTRUMENT

Model Number	420309-05
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The instrument was found to have a broken pitch cable at the distal clevis hub with the crimp missing.Broken strands stuck out at the wrist and the clevis did not exhibit any wear.A device history record (dhr) review for the device involved with this complaint has been completed.No non-conformances were identified to be related to this complaint.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 or Problem Description
It was reported that during a da vinci-assisted surgical procedure, broken cables were observed on the mega suturecut needle driver instrument.There was no report of fragments falling into the patient, patient harm, adverse outcome or injury.

• Brand Name: MEGA SUTURECUT NEEDLE DRIVER
• Common Device Name: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• MDR Report Key: 6270796
• Report Number: 2955842-2017-00044
• Device Sequence Number: 16513330
• Product Code: NAY
• UDI-Device Identifier: 00886874111796
• UDI-Public: (01)00886874111796(10)N1016111
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2016

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: 420309-05
• Device Lot Number: N10161115 780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1