MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS

Model Number 470205-15

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument has not been returned to isi for failure analysis investigations; therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the unit is returned (post engineering evaluation) or if additional information is received. This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, a piece of the fenestrated bipolar forceps instrument broke off and fell into the patient. The broken instrument piece was retrieved from the patient and there was no harm to the patient. However, it is unknown what caused the instrument breakage to occur. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

Event Description

It was reported that during a da vinci assisted incisional hernia repair procedure, during use of the fenestrated bipolar forceps instrument, the instrument broke causing a piece of the instrument to fall into the patient. The broken instrument piece was retrieved during the same surgical procedure and the planned surgical procedure was completed with a replacement instrument. On (b)(6) 2018 intuitive surgical, inc. (isi) contacted the site's assistant nurse manager regarding the reported event. According to the nurse manager, she was not present for the surgical procedure and indicated that she was unable to provide any additional information regarding the reported event at this time.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7315479
• MDR Text Key: 101708719
• Report Number: 2955842-2018-10036
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470205-15
• Device Lot Number: N11171116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage