MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); Perforation (2001); Urinary Retention (2119)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: only event year known: 2019.Batch # unk.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the patient had a history of morbid obesity that underwent laparoscopic roux-en-y gastric bypass.Operative note states a jejunum was divided with an ¿endo-gia white load with seamguard¿ and the side-to-side gastrojejunostomy was performed with the same device but without seamguard.A green load was used horizontally with seamguard and the gastrotomy created.The anvil of a ¿21 eea¿ was placed and two more firings of a green load with seamguard.The antegastric antecolic limb was brought up and the device was attached to the anvil.Operative note provided indicates no difficulty with any stapling devices and the patient tolerated the procedure well and was discharged the following morning.Later that day, the patient returned to the hospital due to worsening epigastric and left upper quadrant abdominal pain and underwent a diagnostic laparoscopy the next day where a ¿small (~5mm) leak at the medial aspect of the gastric pouch staple line¿ was repaired with 2-0 ethibond sutures.She was discharged in good condition eleven days later.

Manufacturer Narrative

(b)(4).Date sent: 01/09/2023.Medical records received.Please see attached.

Manufacturer Narrative

(b)(4).Date sent: 1/25/2023.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3293480130
• MDR Report Key: 15401615
• MDR Text Key: 299677385
• Report Number: 3005075853-2022-05947
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 01/05/2023; 01/05/2023
• Supplement Dates FDA Received: 01/09/2023; 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female