MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM FENESTRATED BIPOLARFORCEPS; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 470205-15

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/04/2018

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, the grasper broke off and fell inside 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.

Event Description

It was reported during a da vinci-assisted hysterectomy procedure, one of the graspers on the fenestrated bipolar forceps instrument broke at the base and fell inside the patient.The fragment was retrieved during the same procedure.There was no report of patient harm, adverse outcome or injury.

• Brand Name: 8 MM FENESTRATED BIPOLARFORCEPS
• 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: 7226768
• MDR Text Key: 98974778
• Report Number: 2955842-2018-00062
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-15
• Device Lot Number: N10171116 0100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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