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

Model Number 420207-07

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

The instrument has not been returned to isi for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.If additional information is received, a follow-up mdr will be submitted.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 tenaculum forceps fell inside the patient.The fragment was retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the cable to fall inside the patient.

Event Description

It was reported that after completion of a da vinci-assisted myomectomy procedure, a fragment from the tenaculum forceps instrument broke off and fell inside the patient.The fragment was retrieved during the same da vinci procedure.The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.

• Brand Name: 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: 7001690
• MDR Text Key: 92071839
• Report Number: 2955842-2017-00736
• Device Sequence Number: 1
• Product Code: NAY
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420207-07
• Device Lot Number: N10161222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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