MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; REDUCER

Model Number 470381-11

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Nausea (1970)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Isi has not received the component involved with this complaint, although it has been requested to be returned for failure analysis.Therefore, the root cause of the alleged customer reported failure mode cannot be determined.The reducer is a single use item and has been discarded by the site.A follow-up mdr will be submitted if the component is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.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, all reusable instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against the instruments.Images provided by the customer were analyzed by advanced failure analysis: the pictures are not in focus, but the part appears to be similar in shape and appearance to the conductive reducer metal tip (pn 334997-04) that is part of sub assembly pn 341529-09, which is used in top level pn 470381-11 (current production release version).Pictures do not provide any insight into potential root cause.The customer should return all components of top level pn 470381-xx to better assess a potential root cause.Toxicology information for the part detailed in the complaint has been provided: the conductive reducer tip was assessed for biocompatibility.This complaint is reportable due to the following: a component that fell inside the patient during a surgical procedure and required a second procedure to remove it is considered an adverse event and a malfunction.There is no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the issue to occur.If additional information becomes available, a follow-up mdr will be submitted.

Event Description

It was reported by the surgeon that during a da vinci-assisted gastric bypass (roux-en-y) procedure on (b)(6) 2021, the metal piece from the cannula reducer separated from the plastic on the cannula and was retained inside the patient.The patient returned with complications and after a ct scan, the metal piece was found.The patient underwent a second procedure to remove the retained component on (b)(6) 2021.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) who was not present for the procedure, but was informed of the event by the surgeon.The following additional information was obtained on 21-oct-2021: there were no known complications during the initial procedure.The csr was not sure what complications the patient experienced post-operatively.The distal metal tip of the reducer had fallen into the patient and a second procedure via laparoscopy was required to remove the component.The patient is currently doing well.Isi followed up with the surgeon and obtained the following information on 27-oct-2021: the surgeon assumed the instruments and accessories were inspected by the scrub tech.Nothing was mentioned to the surgeon about any damaged instruments or accessories prior to the surgery.The reducer was attached to arm 1 on the system and was used throughout the whole procedure without any issues in its functionality.The fenestrated bipolar forceps and cadiere forceps were inserted through the reducer.There was no damage noticed to the cannula or instruments.The surgeon was unsure what caused the accessory to break and cause the component to fall into the patient¿s anatomy.He did not notice the tip of the reducer separating during the procedure.The patient presented 4 months after surgery with a visit to the er for abdominal pain, nausea and dehydration.The surgeon was not sure if these symptoms were directly related to the retained component.A ct scan of the abdomen performed on (b)(6) 2021 showed an intraluminal foreign body in the intestine.An x-ray was performed on (b)(6) 2021 to see the progression of the foreign body and whether the patient would be able to pass it out on her own.This was followed by a diagnostic laparoscopy to remove the item.The component was located in the left upper quadrant area, lying free in the peritoneal cavity with little omental adhesions.Additional bowel tissue was not resected, and the patient recovered well.The patient is currently recovering well from surgery.The component is currently not available to be returned to isi as it is being held by the site¿s pathology department.In relation to the reported event, on (b)(6) 2021 isi received fda voluntary event report #mw5104809 stating: ¿during a robotic procedure the surgeon was using the robotic stapler and the 12-8mm reducer.Part of the reducer (the metal tip) unknowingly fell off and was left behind in the patient.Fda safety report id #(b)(4).¿.

Manufacturer Narrative

D15- isi has not received the component involved with this complaint, although it has been requested to be returned for failure analysis.Therefore, the root cause of the alleged customer reported failure mode cannot be determined.The reducer is a single use item and has been discarded by the site.A follow-up mdr will be submitted if the component is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.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, all reusable instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against the instruments.Images provided by the customer were analyzed by advanced failure analysis: the pictures are not in focus, but the part appears to be similar in shape and appearance to the conductive reducer metal tip (pn 334997-04) that is part of sub assembly pn 341529-09, which is used in top level pn 470381-11 (current production release version).Pictures do not provide any insight into potential root cause.The customer should return all components of top level pn 470381-xx to better assess a potential root cause.Toxicology information for the part detailed in the complaint has been provided: the conductive reducer tip was assessed for biocompatibility.This complaint is reportable due to the following: a component that fell inside the patient during a surgical procedure and required a second procedure to remove it is considered an adverse event and a malfunction.There is no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the issue to occur.If additional information becomes available, a follow-up mdr will be submitted.

Event Description

It was reported by the surgeon that during a da vinci-assisted gastric bypass (roux-en-y) procedure on (b)(6) 2021, the metal piece from the cannula reducer separated from the plastic on the cannula and was retained inside the patient.The patient returned with complications and after a ct scan, the metal piece was found.The patient underwent a second procedure to remove the retained component on (b)(6) 2021.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) who was not present for the procedure, but was informed of the event by the surgeon.The following additional information was obtained on 21-oct-2021: there were no known complications during the initial procedure.The csr was not sure what complications the patient experienced post-operatively.The distal metal tip of the reducer had fallen into the patient and a second procedure via laparoscopy was required to remove the component.The patient is currently doing well.Isi followed up with the surgeon and obtained the following information on 27-oct-2021: the surgeon assumed the instruments and accessories were inspected by the scrub tech.Nothing was mentioned to the surgeon about any damaged instruments or accessories prior to the surgery.The reducer was attached to arm 1 on the system and was used throughout the whole procedure without any issues in its functionality.The fenestrated bipolar forceps and cadiere forceps were inserted through the reducer.There was no damage noticed to the cannula or instruments.The surgeon was unsure what caused the accessory to break and cause the component to fall into the patient¿s anatomy.He did not notice the tip of the reducer separating during the procedure.The patient presented 4 months after surgery with a visit to the er for abdominal pain, nausea and dehydration.The surgeon was not sure if these symptoms were directly related to the retained component.A ct scan of the abdomen performed on (b)(6) 2021 showed an intraluminal foreign body in the intestine.An x-ray was performed on (b)(6) 2021 to see the progression of the foreign body and whether the patient would be able to pass it out on her own.This was followed by a diagnostic laparoscopy to remove the item.The component was located in the left upper quadrant area, lying free in the peritoneal cavity with little omental adhesions.Additional bowel tissue was not resected, and the patient recovered well.The patient is currently recovering well from surgery.The component is currently not available to be returned to isi as it is being held by the site¿s pathology department.In relation to the reported event, on (b)(6) 2021 isi received fda voluntary event report #mw5104809 stating: ¿during a robotic procedure the surgeon was using the robotic stapler and the 12-8mm reducer.Part of the reducer (the metal tip) unknowingly fell off and was left behind in the patient.Fda safety report id #(b)(4).¿.

Manufacturer Narrative

Corrected information can be found in fields: e1, e2, and e3 additional information can be found in fields: e4, g3, g6, h2, and h10.This event was determined to be related to (b)(4).

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: REDUCER
• 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: 12817270
• MDR Text Key: 285931899
• Report Number: 2955842-2021-11508
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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: 470381-11
• Device Catalogue Number: 470381
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: ISIFA2021-08-R
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 187 KG