MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM MEGA SUTURECUT NEEDLEDRIVER; ENDOSCOPIC INSTRUMENT

Model Number	470309-12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the mega suturecut needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis investigations found the instrument 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 suggests that if the malfunction were to recur it could cause or contribute to an adverse event.
Event or Problem Description
The mega suturcut needle driver instrument was returned to intuitive surgical, inc.(isi) without a reported failure.Isi made multiple follow up attempts to obtain additional information, however, no information has been received as of date of this report.

• Brand Name: 8 MM MEGA SUTURECUT NEEDLEDRIVER
• Common Device Name: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• MDR Report Key: 7231380
• Report Number: 2955842-2018-00071
• Device Sequence Number: 13768389
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N11171107
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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): 01/12/2018

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
• Operator of Device: Health Professional
• Device Model Number: 470309-12
• Device Lot Number: N11171107 0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1