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

Model Number	420194-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not received the instrument involved with this complaint for failure analysis investigation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow up mdr will be submitted if the instrument is returned and/or if additional information is received.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that a cable from the mega needle driver instrument broke off and fell inside the patient.Although no patient harm, adverse outcome or injury was reported, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy with bilateral salpingo-oophorectomy procedure, a cable from the mega needle driver instrument snapped and fell inside the patient.All fragments were retrieved with a da vinci prograsp forceps instrument.There was no post-operative tests performed to check for any remaining fragments.There was no report of patient harm, adverse outcome or injury.

• Brand Name: MEGA NEEDLE DRIVER
• Common Device Name: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• MDR Report Key: 7026561
• Report Number: 2955842-2017-00767
• Device Sequence Number: 1256245
• Product Code: NAY
• UDI-Device Identifier: 00886874111611
• UDI-Public: (01)00886874111611(10)N11170410
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/17/2017

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: 420194-10
• Device Lot Number: N11170410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1