MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY SPATULA

Model Number 470184-11

Device Problem Arcing (2583)

Patient Problems Disability (2371); Burn, Thermal (2530)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The site provided four photos of the permanent cautery spatula (pcs) instrument associated with the reported event.Two of the photos show severe thermal damage on the yaw pulley, below the ceramic sleeve.The other two photos show thermal damage present on the proximal clevis ear.The damage is indicative of arcing events.As of the date of this follow-up #1 mdr, intuitive surgical, inc.(isi) has not received the pcs instrument for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined at this time.

Manufacturer Narrative

Isi has requested for the pcs instrument to be returned to isi for evaluation.As of the date of this report, isi has not received the instrument.Therefore, the root cause of the customer reported failure mode and the patient¿s operative complication is unknown.A follow-up mdr will be submitted if additional information is received.The site provided 2 video clips of the alleged arcing event that occurred during the surgical procedure.Isi has reviewed the video clips and provided the following analysis: the video clips show energy leakage from a pcs instrument.In one video clip, arcing from the pcs instrument to an unidentified hand-help laparoscopic instrument is seen when energy is activated.In the second video clip, arcing occurs while the surgeon "air fires." the video clips show the pcs instrument in an already damaged state and do not provide evidence of how the instrument damage occurred initially.The instruments & accessories user manual states the following in relation to permanent cautery instrument: "warning: exercise caution when working with monopolar instruments close to other instruments.Unintended energy may be delivered from the active monopolar instrument to a second instrument.This could result in burns to tissue in contact with any of the second instrument¿s metal parts or its cannula.To exercise caution in these scenarios, the monopolar tip should be closer to the tissue than to the second instrument.- do not apply energy when the instrument tip is not in contact with tissue: energy should not be applied to an instrument when it is not in direct contact with tissue (referred to as ¿air-firing¿).Additionally, do not use an electrosurgical instrument to apply cautery to any other instrument.Warning: as with any electrosurgical device, it is possible for energy to discharge in an area other than the instrument tip.It is important to exercise caution when using an energized endowrist permanent cautery instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized." isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2019.No related system errors were found to have occurred during the surgical procedure.Based on the information provided at this time, this complaint is being reported due to the following: it was alleged that during a da vinci-assisted tors procedure, electrical energy possibly arced from a pcs instrument.However, at this time, the root cause of the alleged arcing issue is unknown.In addition, although a burn injury was reported, there is no evidence that a serious patient injury occurred.Per the initial reporter, the burn injury did not require any medical intervention.

Event Description

It was initially reported that after completion of a da vinci-assisted transoral robotic surgery (tors), the customer noticed a possible burn injury on the patient¿s tongue.The burn injury was described as being white.After the burn injury was identified, the customer inspected the tip of the permanent cautery spatula (pcs) instrument and noticed a dark burn mark near the wrist area.According to the initial reporter, there is speculation that an arcing event had occurred.No special treatment was administered due to the burn injury.On 11/19/2019, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the burn injury was described as being ¿non serious¿ and measured 3.0 cm x 1.5 cm.Also, it was noted that the ¿the damage of the patient¿s tongue may be only surface.¿ no medical intervention was administered due to the burn injury.In addition, no post-operative complications have been reported other than a ¿strong ache.¿ as of (b)(6) 2019, the patient was ¿recovering¿ and starting to eat.

Manufacturer Narrative

61 - intuitive surgical, inc.(isi) has received the instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of thermal damage.The instrument was found to have thermal damage on the monopolar yaw pulley.This failure is most commonly caused by mishandling/misuse.The conductor wire cap was not damaged.There was no damage to the conductor wire weld.The instrument passed an electrical continuity test.The instrument was also found to have thermal damage on one of the distal clevis ears.This failure is most commonly caused by mishandling/misuse.It was confirmed that the conductor wire was not broken at the weld and the silicone potting was intact where the wire enters the yaw pulley.Since there was no wire damage (neither broken nor damaged insulation), a possible cause of the thermal damage is "air firing" (activation of cautery without the tip contacting tissue).Air firing is considered misuse.Based on the additional information provided, there is no evidence that a reportable malfunction of the permanent cautery spatula instrument occurred.The instrument damage found by failure analysis can be attributed to misuse/mishandling.

Manufacturer Narrative

Initial mdr h10/h11 submitted on 11/22/2019: 4315, 67 ¿ isi has requested for the pcs instrument to be returned to isi for evaluation.As of the date of this report, isi has not received the instrument.Therefore, the root cause of the customer reported failure mode and the patient¿s operative complication is unknown.A follow-up mdr will be submitted if additional information is received.The site provided 2 video clips of the alleged arcing event that occurred during the surgical procedure.Isi has reviewed the video clips and provided the following analysis: the video clips show energy leakage from a pcs instrument.In one video clip, arcing from the pcs instrument to an unidentified hand-help laparoscopic instrument is seen when energy is activated.In the second video clip, arcing occurs while the surgeon "air fires." the video clips show the pcs instrument in an already damaged state and do not provide evidence of how the instrument damage occurred initially.The instruments & accessories user manual states the following in relation to permanent cautery instrument: "warning: exercise caution when working with monopolar instruments close to other instruments.Unintended energy may be delivered from the active monopolar instrument to a second instrument.This could result in burns to tissue in contact with any of the second instrument¿s metal parts or its cannula.To exercise caution in these scenarios, the monopolar tip should be closer to the tissue than to the second instrument.- do not apply energy when the instrument tip is not in contact with tissue: energy should not be applied to an instrument when it is not in direct contact with tissue (referred to as ¿air-firing¿).Additionally, do not use an electrosurgical instrument to apply cautery to any other instrument.Warning: as with any electrosurgical device, it is possible for energy to discharge in an area other than the instrument tip.It is important to exercise caution when using an energized endowrist permanent cautery instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized." isi has reviewed the site¿s system logs with a procedure date of 11/13/2019.No related system errors were found to have occurred during the surgical procedure.Based on the information provided at this time, this complaint is being reported due to the following: it was alleged that during a da vinci-assisted tors procedure, electrical energy possibly arced from a pcs instrument.However, at this time, the root cause of the alleged arcing issue is unknown.In addition, although a burn injury was reported, there is no evidence that a serious patient injury occurred.Per the initial reporter, the burn injury did not require any medical intervention.Follow-up mdr #1 h10/h11 submitted on 12/06/2019: the site provided four photos of the permanent cautery spatula (pcs) instrument associated with the reported event.Two of the photos show severe thermal damage on the yaw pulley, below the ceramic sleeve.The other two photos show thermal damage present on the proximal clevis ear.The damage is indicative of arcing events.As of the date of this follow-up #1 mdr, intuitive surgical, inc.(isi) has not received the pcs instrument for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined at this time.Follow-up mdr #2 h10/h11 submitted on 12/26/2019 61 - intuitive surgical, inc.(isi) has received the instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of thermal damage.The instrument was found to have thermal damage on the monopolar yaw pulley.This failure is most commonly caused by mishandling/misuse.The conductor wire cap was not damaged.There was no damage to the conductor wire weld.The instrument passed an electrical continuity test.The instrument was also found to have thermal damage on one of the distal clevis ears.This failure is most commonly caused by mishandling/misuse.It was confirmed that the conductor wire was not broken at the weld and the silicone potting was intact where the wire enters the yaw pulley.Since there was no wire damage (neither broken nor damaged insulation), a possible cause of the thermal damage is "air firing" (activation of cautery without the tip contacting tissue).Air firing is considered misuse.Based on the additional information provided, there is no evidence that a reportable malfunction of the permanent cautery spatula instrument occurred.The instrument damage found by failure analysis can be attributed to misuse/mishandling.New additional/corrected information (follow-up mdr #3): 4307 - intuitive surgical, inc.(isi) has received the permanent cautery spatula instrument associated with this complaint and completed device investigations.Failure analysis confirmed the reported complaint of thermal damage on the yaw pulley.The monopolar yaw pulley, distal clevis, and proximal clevis were found to have incurred thermal damage.The conductor wire cap was not damaged.There was no damage to the conductor wire weld.The instrument passed an electrical continuity test.It was confirmed that the conductor wire was not broken at the weld and the silicone potting was intact where the wire enters the yaw pulley.As of 04/21/2020, 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 instrument log for the permanent cautery spatula (pn: 470184-11, batch/lot-sequence: n10170109-0030) associated with this event has been performed.Per logs, the instrument was last used on 11/13/2019 on system sk0462 with 7 lives remaining on the instrument.While the burns were noted to be surface level, ¿non-serious,¿ and did not require medical intervention, this complaint is being reported as an adverse event because the doctor could not exclude the possibility of permanent impairment resulting in a taste disorder or other complication.This complaint is also being reported as a product problem because thermal damage proximal to the ceramic sleeve is evidence of electrical discharge at a location other than intended, which could cause or contribute to an adverse event if it were to recur.Updated fields: b1 was updated to "adverse event and product problem" per the reportability statement above.B2 was updated to "permanent damage" as the doctor could not exclude the possibility of permanent damage.B4 and g4 were updated to "11/19/2019" as that was the date that isi received information suggesting that permanent damage may have occurred.D4 was updated to include the permanent cautery spatula instrument's catalog information as it was not provided in previous reports.H6 result codes were updated to include code 642.H6 patient problem codes were updated to include code 2371 in addition to code 2530.H6 conclusion codes were updated to code 4307 as there is evidence to suggest that electrical current was discharged at a location other than intended.This report has been generated in response to fda inspectional observations dated 3/6/2020.

Event Description

Initial mdr b5 submitted on 11/22/2019: it was initially reported that after completion of a da vinci-assisted transoral robotic surgery (tors), the customer noticed a possible burn injury on the patient¿s tongue.The burn injury was described as being white.After the burn injury was identified, the customer inspected the tip of the permanent cautery spatula (pcs) instrument and noticed a dark burn mark near the wrist area.According to the initial reporter, there is speculation that an arcing event had occurred.No special treatment was administered due to the burn injury.On 11/19/2019, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the burn injury was described as being ¿non serious¿ and measured 3.0 cm x 1.5 cm.Also, it was noted that ¿the damage of the patient¿s tongue may be only surface.¿ no medical intervention was administered due to the burn injury.In addition, no post-operative complications have been reported other than a ¿strong ache.¿ as of (b)(6) 2019 the patient was ¿recovering¿ and starting to eat.New additional/corrected information: on 11/19/2019, isi obtained the following additional information regarding the reported event: the burn injury was described as being ¿non serious¿ and measured 3.0 cm x 1.5 cm.Also, it was noted that ¿the damage of the patient¿s tongue may be only surface.¿ no medical intervention was administered due to the burn injury.In addition, no post-operative complications have been reported other than a ¿strong ache.¿ as of (b)(6) 2019 the patient was ¿recovering¿ and starting to eat.However, the doctor could not exclude the possibility of a taste disorder or other complication.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9362889
• MDR Text Key: 175763672
• Report Number: 2955842-2019-10918
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)N10170109
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-11
• Device Catalogue Number: 470184
• Device Lot Number: N10170109 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Disability