MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. FENESTRATED BIPOLAR FORCEP; DA VINCI SI/S FENESTRATED BIPOLAR FORCEPS

Model Number DA VINCI SI

Device Problems Break (1069); Component Missing (2306)

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

Event Date 10/31/2016

Event Type  malfunction  

Event Description

Defective - 420205-10/n10160628 729.No fragments reported fell into patient.Grip failure/instrument just not working reported.After examination, discovered piece missing from yaw pulley area of instrument.Same area of failure as other rma's previous.Attn: (b)(6).Did any fragments fall into the patient: no.Was there any patient harm: no.Returned to vendor 11/22/2016.Intuitive surgical inc.Failure analysis reporting."failure analysis investigations found broken on the following location instrument bipolar yaw pulley - evidence not conclusive, but broken damage may be due to likely mishandling/ misuse." (b)(4).

• Brand Name: FENESTRATED BIPOLAR FORCEP
• Type of Device: DA VINCI SI/S FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6979175
• MDR Text Key: 90408592
• Report Number: MW5072955
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI SI
• Device Catalogue Number: 420205-10
• Device Lot Number: N10160628-729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1