MAUDE Adverse Event Report: INTUITIVE SURGICAL INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number 470400-07

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Isi has not received the instrument involved with this complaint, therefore the root cause of the customer reported failure cannot be determined.A follow up mdr will be submitted if the instrument is returned and/or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment broke off and fell inside the patient.Although, the fragment was retrieved and no patient harm was reported, it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure, a piece of plastic from the long bipolar grasper instrument broke off and fell inside the patient.The fragment was retrieved during the same surgical procedure.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) has made multiple follow up attempts to obtain additional information, however, no additional information has been received as of date of this report.

• Brand Name: ENDOWRIST
• Type of Device: BIPOLAR GRASPER, LONG
• Manufacturer (Section D): INTUITIVE SURGICAL INC; 1020 kifer road; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL INC; 1020 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 1020 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7289714
• MDR Text Key: 101010748
• Report Number: 2955842-2018-10011
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)S10170629
• Combination Product (y/n): N
• PMA/PMN Number: K150837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470400-07
• Device Lot Number: S10170629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1