MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MARYLAND BIPOLAR FORCEPS

Model Number 471172-16

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that after a da vinci-assisted pancreaticoduodenectomy procedure, the patient had bleeding on the 1st post-operative day (pod) and a laparotomy was performed.The bleeding point was the inferior pancreaticoduodenal vein (ipdv).Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: during the primary procedure and after applying a small clip on the ipdv, a vessel sealer extend (vse) instrument or maryland bipolar forceps (mbf) instrument was used to seal the vessel.The surgeon was unable to recall which specific instrument was used to seal the ipdv.According to the customer, the vein was subsequently cut with the vse instrument or mbf instrument.The primary procedure was completed with no issues.There were no problems with applying the clip(s) during the procedure.On the pod #1, the patient experienced "high bleeding" and underwent a laparotomy.The source of the bleeding was found to be the "sealing point" of the ipdv.The amount of bleeding was more than 1000 ml and the patient received a blood transfusion.The customer was unable to confirm if clip was present on the ipdv during the laparotomy.The surgeon believes the bleeding was due to insufficient sealing of the ipdv and was related to use of the small clip applier instrument or mbf instrument, although the customer indicated that the vessel was successfully clipped during the initial robotic procedure.In addition, it could not be confirmed if the surgeon had experienced cautery issues with the mbf instrument or insufficient sealing with the vse instrument during the initial robotic procedure.The surgeon stated that the primary procedure was ¿difficult¿ as the head of the pancreas was lying at the dorsal side of the superior mesenteric artery (sma), but it is unknown if anatomical reasons contributed to the bleeding.The site did not provide any video for review.The site declined to return the instruments.Demographic information was enquired but not provided.Since the surgeon is unsure which instrument caused the post-operative complication, a medwatch report (mdr) will be submitted each for the vse instrument, small clip applier instrument, and mbf instrument.This mdr is being submitted for the mbf instrument.

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication is unknown.The customer declined to return the instruments to isi for evaluation.A follow-up mdr will be submitted if additional information is received.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Additionally, the mbf instrument used in this case has been reused in a subsequent procedure and a site review shows no complaint filed against the instrument.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted pancreaticoduodenectomy procedure which was performed without any issues, the patient experienced bleeding on pod #1 and a laparotomy was performed.The source of bleeding was the "sealing point" on the ipdv.The amount of bleeding was more than 1000ml and the patient required a blood transfusion.During the initial robotic procedure, the surgeon had placed a small clip on the ipdv with a small clip applier instrument prior to sealing and cutting the vessel with a vse instrument or mbf instrument.The surgeon could not recall which specific instrument was used for sealing the ipdv.The surgeon believes that the post-operative bleeding was to insufficient sealing.However, the customer could not confirm if the post-operative bleeding was related to use of the small clip applier instrument, the mbf instrument, or vse instrument.Refer to medwatch report (mdr) with patient identifier #(b)(6) for information regarding the mbf instrument associated with the reported event.Refer to medwatch report (mdr) with patient identifier #(b)(6) for information regarding the vse instrument associated with the reported event.Refer to medwatch report (mdr) with patient identifier #(b)(6) for information regarding the small clip applier instrument associated with the reported event.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14136121
• MDR Text Key: 289447443
• Report Number: 2955842-2022-11126
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10211116
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: K10211116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES