MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420179-15

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Injury (2348)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

On 07-14-2017 intuitive surgical, inc. (isi) received additional information from the site's initial reporter of this complaint. According to the initial reporter, she spoke with the surgeon who performed the planned surgical procedure. The surgeon indicated that the patient sustained a serosa injury that was repaired by the site's general surgeon. It is unknown how the injury occurred and he is not sure if the mcs instrument caused the injury. The patient did not experience any post-operative complications and was discharged home the following day. There is no video recording of the planned surgical procedure. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the mcs instrument and the mcs tip cover accessory involved with this complaint and completed investigations. Failure analysis confirmed the customer reported complaint. The instrument was found to have a broken tube extension, causing a piece to bulge out. Evaluation also found that the instrument's tube extension exhibited deep scratch marks and the pad printing was removed. It was concluded that the damage to the instrument's tube extension was due to mishandling/misuse. No other damage was found. The mcs tip cover accessory was visually inspected and the midpoint of the tip cover accessory exhibited a 0. 283 tear. Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the mcs instrument with the mcs tip cover accessory installed bent, surgeon lost control, and there was a bowel injury to the patient identified. Failure analysis concluded that the damage to the instrument was due to mishandling/misuse and not due to a malfunction of the device. However, at this time it is unknown what caused the bowel injury to the patient.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure, the monopolar curved scissors (mcs) instrument with the mcs tip cover accessory installed, bent causing the surgeon to loose control of the instrument. Reportedly, the patient sustained a large bowel injury. The site installed a replacement mcs instrument and tip cover accessory. The planned surgical procedure was reported to have been completed and the damage to the patient's large bowel was repaired by the site's general surgeon. Intuitive surgical, inc. (isi) made multiple follow up attempts to obtain additional information regarding the reported event. However, no further information was obtained as of date of this report.

• Brand Name: MONOPOLAR CURVED SCISSORS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 6712373
• MDR Text Key: 210158706
• Report Number: 2955842-2017-00446
• 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: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 420179-15
• Device Lot Number: N11170427 087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/13/2017 Patient Sequence Number: 1