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

Model Number NSLX137C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Pleural Effusion (2010)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: is there any surgical video available of 1st procedure for medical & engineering review? what was the approximate distance between device and the fundus when ligating short gastric vessel? was there any white blanching observed on the fundus of stomach in the original procedure? describe in detail the timing of post op complications.How did they detect the post-op complications? what is the patient's current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.

Event Description

It was reported that during a lap nissens procedure the surgeon used the device for the first time.The rep coached him some but there wasn't anything wrong with his technique.There were some post op complications so the patient was taken back to theatre.A different surgeon performed a laparotomy and noticed a hole in the fundus which was then stapled to close.His best guess was it was caused by a diathermy.However, the only energy device used was the enseal, no monopolar.The patient is fine and stable.No generator issues and device functioned as it should throughout the entire procedure.

Manufacturer Narrative

(b)(4).Date sent: 11/23/2021.Additional information was requested and the following was obtained: what was the approximate distance between device and the fundus when ligating short gastric vessel? was there any white blanching observed on the fundus of stomach in the original procedure? describe in detail the timing of post op complications.How did they detect the post-op complications? what is the patient's current status? 1.The short gastric in this occasion were close to the fundus but no closer than normal 2.Patient had the procedure on the tuesday and was discharged on the wednesday morning.Represented late in the evening of the thursday.Ct scan suggested fluid and taken to theatre the next morning,friday.3.Ct, deteriorating clinical picture, and at laparotomy.4.Recent readmission with pleural effusion-needing drain.Discharged home 3days ago.

• 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: 12821657
• MDR Text Key: 283832042
• Report Number: 3005075853-2021-06967
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention