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 Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Ejection Problem (4009)

Patient Problems Abscess (1690); Adhesion(s) (1695); Inflammation (1932); Hernia (2240); Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: only event year known: 2022.Batch # unknown.(b)(4).An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system 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 the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

Event Description

It was reported that the patient presented with long history of crohn¿s disease and recent history of sigmoid stricture, left colon stricture, ileocecal stricture and meckel¿s diverticulum underwent a laparoscopic converted to open sigmoidectomy, left hemicolectomy with colostomy creation, right hemicolectomy with ileocolostomy anastomosis and small bowel resection with side to side anastomosis.Five months later, patient underwent exploratory laparotomy, extensive lysis of adhesions, omentectomy, colostomy takedown, and creation of loop ileostomy.Patient noted to have crohn¿s disease.Surgeon noted that the ¿ils 29-mm stapler¿ was closed and fired, but the stapler was ¿having difficulty with removal and upon removal it appeared that the stapler had fired; however, the cut had not been performed and this caused a tear in the rectum as well as the distal colon.¿ the surgeon oversewed the rectal stump with sutures, and there was no air leak identified upon testing.The surgeon used another ils 29-mm stapler, and, upon closing, noticed a tear in the anterior aspect of the colon, which was sutured.Once complete, the stapler was ¿fired and removed without difficulty.¿ anastomotic rings were intact and no air leak was identified.Due to inflammation in the colon and difficulty with the anastomosis, the surgeon decided to divert the patient with a loop ileostomy.The patient tolerated the procedure well and was discharged ten days later.Almost a year later, the patient underwent a robotic assisted laparoscopic lysis of adhesions, revision of anastomosis, ileostomy takedown and repair of small bladder injury and ventral hernia repair.A year later, patient developed abdominal wall abscess and underwent repair of prolapse, colostomy with colon resection, complex repair of parastomal hernia with takedown and relocation with new creation of ileostomy and drainage of abscess.

Manufacturer Narrative

(b)(4).Date sent: 06/01/2022.Please see attached medical record.

Manufacturer Narrative

(b)(4).Date sent: 05/23/2022.

• 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
• MDR Report Key: 14307549
• MDR Text Key: 290921688
• Report Number: 3005075853-2022-02891
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• 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: 49 YR
• Patient Sex: Male