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

Model Number 400180

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

The instrument accessory has not been returned for evaluation.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.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.The mcs instrument involved with the reported event was used during a subsequent surgical procedure.No complaints were reported to isi against the mcs instrument.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the mcs tip cover accessory allegedly fell off inside the patient and was not retrieved.The patient underwent a subsequent unspecified procedure to retrieve the mcs tip cover accessory which was found in subcutaneous tissue.However, the root cause of the customer reported failure mode is unknown.

Event Description

It was initially reported that during a da vinci-assisted low anterior resection procedure, the monopolar curved scissors (mcs) tip cover accessory installed on a mcs instrument allegedly fell off inside the patient and was not retrieved.The surgeon made the decision to close the patient after spending three hours searching for the mcs tip cover accessory which was not found.The patient and his/her family were notified of the missing instrument accessory.On 09/25/2017, 09/26/2017, and 09/27/2017, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event from an isi clinical sales representative (csr): the mcs tip cover accessory was installed with the installation tool.According to the csr, the instrument accessory appeared to have been installed properly.The surgeon was unsure as to why the mcs tip cover accessory fell off the mcs instrument.No resistance was felt while the mcs instrument was removed through the cannula.Upon removal, the instrument's wrist was reportedly straightened.The csr indicated that the patient underwent an unspecified post-operative procedure on an unspecified date to retrieve the missing mcs tip cover accessory which was found in subcutaneous tissue.The csr stated that the mcs tip cover accessory was not found in the patient's abdomen.The csr indicated that the instrument accessory is not available for return to isi for evaluation.No damage was identified around the tip of the mcs instrument.

Manufacturer Narrative

In relation to the reported event, intuitive surgical, inc.(isi) received fda uf/importer report (b)(4) with the following event description: tip cover used to protect robotic instrument during procedure came off.In place for the majority of the procedure.Surg tech noted it missing when removed from the abdominal cavity.Surgeon informed.Laparoscopic search conducted, transition to hand-assisted laparoscopic, then conversion to open laparotomy to facilitate thorough cavity search.Radiology films taken and reviewed by radiologist prior to conversion open.Tip cover not visualized on the film.Film taken of a new tip cover to provide comparison for radiologist.Tip cover not radiopaque.After tip cover reported missing a thorough search of the room, trash and linen conducted.Abdominal ap and lateral x ray was performed and read by the on duty radiologist after which more intra-abdominal and pelvic searching was performed.At the discretion of the surgeon search ng [sic] was discontinues [sic] and the abdomen was closed.All other surgical counts were performed per policy and found to be correct.It was retrieved from the subcutaneous tissue in a separate procedure.Based on the current information provided, this complaint will remain reportable due to the following conclusion: during the da vinci-assisted surgical procedure, the mcs tip cover accessory allegedly fell off inside the patient and was not retrieved.The patient underwent a subsequent unspecified procedure to retrieve the mcs tip cover accessory which was found in subcutaneous tissue.However, the root cause of the customer reported failure mode is still unknown.

• 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: 6902221
• MDR Text Key: 87721217
• Report Number: 2955842-2017-00637
• Device Sequence Number: 1
• Product Code: NAY
• 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,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention