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	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fenestrated bipolar forceps instrument has not been returned for 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.This complaint is being reported due to the following conclusion: during a da vinci-assisted total benign hysterectomy procedure, a piece of the ceramic sleeve broke off and fell inside the patient.The broken fragment was retrieved.Although, no patient harm was reported at this time it is unknown what caused the instrument fragment to break off and fall inside the patient.
Event or Problem Description
It was reported that during a da vinci-assisted total benign hysterectomy procedure, a piece of the ceramic sleeve from a fenestrated bipolar forceps instrument broke off and fell inside the patient.The fragment was retrieved laparoscopically and the site performed an x-ray test to check for remaining fragments.The instrument was inspected prior to use.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint.Failure analysis confirmed the customer reported complaint.The instrument was found to have a broken clevis.One of the ears of the clevis, along with a grip tip and pin, broke off the tip.All fragment(s) appeared to be returned with the instrument.As a result of the physical damage, the inner components of the wrist were exposed.The known common cause of this failure is mishandling/misuse.Based on the failure analysis results, this mdr report is being retracted due to the following conclusion: there is no evidence that the isi device caused or contributed to an adverse event or that the isi device malfunctioned in a way that could contribute to an adverse event if it were to recur.This event involved fragments falling into a patient and were successfully retrieved.The instrument was returned to isi, evaluated, and it was determined that the instrument damage was likely due to mishandling/misuse.

• Brand Name: 5 MM FENESTRATED BIPOLAR FORCE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• MDR Report Key: 6909233
• Report Number: 2955842-2017-00644
• Device Sequence Number: 699475
• Product Code: NAY
• UDI-Device Identifier: 00886874112106
• UDI-Public: (01)00886874112106(17)190331(10)M10170331
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K130726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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: M10170331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1