MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SUCTION/IRRIGATOR

Model Number	410299-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suction irrigator instrument has not been returned to intuitive surgical, inc.For failure analysis evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Based on the information provided, this complaint is being reported due to the following conclusion: all fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported during a da vinci-assisted lower anterior resection procedure that tip of the endowrist suction irrigator tip fell off the instrument in patient's abdomen.The tip was retrieved and the procedure completed with no report of patient injury nor harm.Follow-up: on 1/28/2019, the site robotics coordinator (roco) was contacted and additional information was obtained about the complaint: roco indicated she does not have a record of sending the instrument for rma therefore it may still be with their risk management department.Roco confirmed the broken fragment was retrieved during the same procedure and there is no report of patient injury nor harm.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SUCTION/IRRIGATOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8287492
• Report Number: 2955842-2019-10067
• Device Sequence Number: 11089505
• Product Code: NAY
• UDI-Device Identifier: 00886874111109
• UDI-Public: (01)00886874111109(17)190331(10)M10170302
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K110451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 410299-03
• Device Lot Number: M10170302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2018-04-C
• Patient Sequence Number: 1