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

Model Number 420205-13

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument has not been returned to isi for failure analysis evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) 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, adverse outcome or injury was reported, it is unknown what caused the breakage to have occurred.

Event Description

It was reported that during a da vinci-assisted hysterectomy with bso procedure, while attempting to bend a needle, a piece of the jaw from the fenestrated bipolar forceps instrument broke off and fell inside the patient.The fragment was retrieved from the patient during the same da vinci 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 regarding the reported event, however, no additional information has been received as of date of this report.

• Brand Name: FENESTRATED BIPOLAR FORCEPS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7122068
• MDR Text Key: 95773603
• Report Number: 2955842-2017-00849
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10170810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-13
• Device Lot Number: N10170810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1