MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM TENACULUM FORCEPS; ENDOSCOPIC INSTRUMENT

Model Number 470207-08

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation found that the instrument pitch cable was broken at the distal clevis hub.The cable segment that contained the crimp was missing from the clevis.No other damage or wear marks were observed on the clevis.A device history record (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument.This complaint is being reported due to the following conclusion: during a da vinci-assisted myomectomy procedure, fragment(s) from the instrument broke off and fell inside the patient.The broken fragment(s) were retrieved without patient harm, adverse outcome or injury.Furthermore, failure analysis investigation confirmed a broken pitch cable and the broken fragment was a crimp from the tenaculum forceps instrument.A broken pitch cable could cause or contribute to an adverse event if the malfunction were to recur.

Event Description

It was reported that during a da vinci-assisted myomectomy procedure, the wires from the tenaculum forceps instrument broke and fragment(s) fell inside the patient.The surgeon was able to retrieve the fragment(s) with a laparoscopic instrument and the planned surgical procedure was completed.There was no report of any patient harm, adverse outcome or injury.

• Brand Name: 8 MM TENACULUM FORCEPS
• Type of Device: ENDOSCOPIC 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: 7227920
• MDR Text Key: 98846053
• Report Number: 2955842-2018-00066
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(10)N10170829
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K013416
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470207-08
• Device Lot Number: N10170829 0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 58