MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; FENESTRATED BIPOLAR FORCEPS

Model Number 420205

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Isi has not received the instrument involved with this complaint, 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.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment from the instrument broke off and fell inside the patient.The fragment was retrieved with no report of patient harm, adverse outcome or injury.However, at this time it is unknown what caused the breakage to occur.

Event Description

Per medwatch uf/importer report # (b)(4), the following was reported: "during robot assisted laparoscopic inguinal hernia (lih) repair - surgeon was using fenestrated bipolar grasper to pull suture through tissue and one of two "arms" on grasper broke off inside patient.Piece was able to be retrieved.".

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7357658
• MDR Text Key: 103286646
• Report Number: 2955842-2018-10086
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10170925
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

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
• Device Operator: Health Professional
• Device Model Number: 420205
• Device Lot Number: N10170925
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• 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
• Patient Age: 56 YR