MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 5 MM FENESTRATED BIPOLAR FORCE; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number	428093-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument has not been returned to isi for failure analysis.Therefore, the root cause of the reported failure cannot be determined.A follow up mdr will be submitted 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 fall inside the patient.The broken fragment was retrieved and no harm, adverse outcoem or injury was reported.However, at this time, 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, the tip of the fenestrated bipolar forceps instrument broke off and fell inside the patient.The broken fragment was retrieved during the same procedure.There was no report of patient harm, adverse outcome or injury.Intuitive surgical (isi) contacted the initial reporter to obtain additional information, however, and no further details have been obtained as of date of this report.

• Brand Name: 5 MM FENESTRATED BIPOLAR FORCE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• MDR Report Key: 6520930
• Report Number: 2955842-2017-00246
• Device Sequence Number: 739252
• Product Code: NAY
• UDI-Device Identifier: 00886874112106
• UDI-Public: (01)00886874112106(17)181031(10)M10161026
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130726
• 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): 03/30/2017

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: 428093-13
• Device Lot Number: M10161026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1