MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX137C

Device Problems Activation, Positioning or Separation Problem (2906); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: v9511d.Additional information was requested and the following was obtained: an internal rapid response call was held on (b)(6) 2021 to include post market surveillance, customer quality, quality engineering, sales, medical safety, marketing, design engineering, and local associates to discuss hemostasis issues with the enseal x1 curve jaw.The rep indicated the account converted to ethicon products in june.They had used the large jaw in the past and had fairly good success.All of the procedures were recorded under a different program, but we will not have access to the videos until after they have been de-identified.The rep chose to go over the nephrectomy cases first.The surgeon is a urologist and was a ligasure user prior to the conversion.The rep was not in the 1st case but an engineer was there.When the rep talked to him, the surgeon said the case may have to be flipped to open and the case went fine/medium.The rep attempted to attend the 2nd case but the surgeon said no because he was having a lot of issues with bleeding and lack of sealing.Per the head of surgery, the operating surgeon had to convert the procedure to open to control the heavy bleeding and the structure that bled was the ¿venus.¿ a significant loss of blood, 300cc, was mentioned.The operating surgeon then looped the 1st case in with the 2nd case indicating he had issues with the device in both cases.The surgeon was adamant that the device was not performing the was it should to the detriment of his patients.He was disenchanted with the device.He also indicated that the device throws out a lot of heat compared to the ligasure.Per engineering request, the rep indicated the surgeon does not always fully lock the device while using it and the surgeon has used the x1 10-15 times.Both nephrectomy devices are coming back.Once the generator serial numbers are pulled from the devices from the engineers, the reps will pull the generator logs.The 3rd case was a laparoscopic cholecystectomy that was performed by a general trauma surgery who normally uses ligasure on his gall bladders.The surgeon indicated that the device was not sealing the cystic artery.The 4th case, a new complaint from (b)(6), was a bowel stricture.The mesentery vessels were not sealing.The surgeon indicated that he will not use the device again.Per engineer¿s inquiry, the rep indicated the surgeon was using the device per the proper technique.The surgeon had to use multiple silk ties to control the bleeding.The device is coming back but no video is available.He used a ligasure maryland to finish case.This surgeon also commented that device seems to get hot.Pms indicated that post op bleeding and intra operative oozing has a very low occurrence rate.The next steps are to get the devices back and will inform the reps what logs that are needed.Then we will circle back to see who would like to talk about the analysis results.Video analysis: unable to determine which analysis corresponds with this complaint.The initial mobilization with the enseal device is very good.The device appeared to work very well through the first 42 minutes of the procedure around the 42nd minute the surgeon attempts to seal and transect a vessel on the posterior side of the kidney.Prior to placing the energy device on tissue, the surgeon performs a lot of posterior dissection with his fingers.Prior to placing the energy device on the vessel, the surgeon is seen drying the field with a sponge.As the surgeon applies the energy device to the tissue, you can see the blood pooling and it looks like the device may be fully submerged in fluid/pool of blood prior to activation.The surgeon transitioned to using a number of endocutter firings to further transect and mobilize the posterior structure of the kidney.After the kidney was fully detached the bed where the kidney was looked fairly dry.The surgeon proceeded to take out some lymph nodes with the device.Except for the one firing in the fluid filled field the device performance look very good.Video #471.In this video, the surgeon experience some bleeding/oozing from the lower pole of the kidney.It was very difficult for me to identify how the bleeding was caused.It was unclear if this was device related or caused by the finger dissection performed by the surgeon, which is a very common technique in the avascular tissue planes surrounding the capsule of the kidney.The surgeon packed the lower pole of the kidney and proceeded with his dissection.There were a lot of activations of the device in a fluid filled field and some activations.The instrument was completely submerged.This was a very large and challenging kidney.The surgeon switched to the harmonic 1100 and he was still getting some oozing.49 minutes into the procedure the screen went black assuming the procedure was converted to open.An internal rapid response call was held on (b)(6) 2021 to include post market surveillance, customer quality, quality engineering, sales, medical safety, marketing, design engineering, and local associates to discuss enseal analyses.The rep gave an overview on the status of the account over the last 2 weeks.They have allowed reprocessed ligasure back into the regular or.The overall sentiment is starting to spread.The engineering team went through the device analyses.There were no issues with any of the devices but 2 of the 3 devices came back very ¿dirty¿/with ¿charring.¿ this issue could potentially be a factor in the sealing issues.Per the reps, there¿s a good chance these devices were used in bloody fields.The reps went through how the different surgeons were doing the steps for use.Pms confirmed that this is a very unusual occurrence.Worldwide, hemostasis issues are occurring less than 1%.The next steps are the reps will pull the generator logs of the generators the devices were used on, and they will reach out to the surgeons to see if they are willing to share any videos.Reps have requested analysis letters with photos.The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslx137c device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.The event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic nephrectomy the surgeon had poor sealing of the venus.The patient lost 300 cc of blood.The surgeon converted to open to address the issue.Patient was still in surgery at the time of reporting the issue.

Manufacturer Narrative

(b)(4).Date sent: 11/9/2021.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslx137c device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.H10 - investigation summary.

Manufacturer Narrative

(b)(4).Date sent: 12/9/2021.Additional information was requested and the following was obtained: an internal rapid response call was held on 11/18/2021 to include post market surveillance, customer quality, quality engineering, sales, medical safety, marketing, design engineering, and local associates to discuss all the findings from device analysis and video observations.Engineering went through how the devices were processed and analyzed once they are returned.Then they went through each analysis of the returned devices in detail.Marketing and the senior director of medical affairs went through the major observations that were made from the 2 shared videos.Reps indicated that this information was very helpful and they would like to get an external rrt call scheduled with the customer to go over the findings.Reps will provide a couple of possible dates and a meeting will be scheduled from there.An external rapid response call was held on 12/8/2021 to include the customer (manager and surgeon), post market surveillance, customer quality, quality engineering, sales, medical safety, marketing, design engineering, and local reps to discuss the analysis performed by the eithicon team.Quality went through our procedure of analyzing a returned device.Then the analysis findings were presented.For (b)(4), the engineer went through the device analysis.He also talked through the excessive tissue on the jaws and cleaning the device.The team also talked though the option of using electrolube.Pms went through the global data.Over 65000 devices have been used in procedures.The occurrence of intra-operative hemostasis concerns and post-operative hemostasis concerns were both well below the limits.The team then went through the videos that were shared with the ethicon team.Both videos show a wetter field and that the instrument was sitting a pool of fluid/blood.It was indicated that the field should be as dry as possible.The next steps are for the customers to work with the local team for a plan for the affected surgeons.

• Brand Name: ENSEAL X1 CURVED 37CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12714902
• MDR Text Key: 284458415
• Report Number: 3005075853-2021-06497
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• 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,Followup
• Report Date: 10/28/2021

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: NSLX137C
• Device Catalogue Number: NSLX137C
• Device Lot Number: V9511D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 10/19/2021; 11/18/2021
• Supplement Dates FDA Received: 11/09/2021; 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.
• Patient Outcome(s): Required Intervention