MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

As of the date of this reported, the mcs tip cover accessory involved with this complaint has not been located.Therefore, the root cause of the customer reported failure mode cannot be determined.Isi has attempted to contact the site to obtain additional information concerning the reported event; however, no additional information has been provided as of the date of this report.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2017.No related system errors were found to have occurred during the surgical procedure.In addition, the mcs instrument (part 470179-14; lot n10170427-0064) used during the reported event was used in subsequent da vinci-assisted surgical procedures with no reported issues.This complaint is being reported due to the following conclusion: after completion of a da vinci-assisted surgical procedure, the mcs tip cover accessory that was installed on the mcs instrument was found to be missing.At this time, the location of the missing mcs tip cover accessory is unknown.It is unclear if the mcs tip cover accessory fell inside the patient and was retained.

Event Description

It was reported that after completion of a da vinci-assisted nephrectomy procedure, the monopolar curved scissors (mcs) tip cover accessory that was installed on a mcs instrument was found to be missing.On 08/07/2017, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following information regarding the reported event: the csr was not present during the surgical procedure.He did not know if the surgical procedure was recorded on video.He also did not know if the missing mcs tip cover accessory actually fell inside the patient during the surgical procedure and was retained.According to the csr, the surgical staff performed an unspecified scan on the patient but the mcs tip cover accessory was not found.No post-operative complications have been reported.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY
• 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: 6820713
• MDR Text Key: 83653597
• Report Number: 2955842-2017-00567
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other