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); Failure to Eject (4010); Firing Problem (4011)

Patient Problems Fistula (1862); Tissue Damage (2104); No Code Available (3191)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.The lot/ batch was not provided; therefore, the manufacturing record evaluation could not be performed.

Event Description

It was reported, patient underwent a laparoscopic sigmoid colectomy with a 29 eea surgical staple gun and colon was perforated.¿the stapler misfired or i pulled the trigger but when i took it out it tore and pulled the whole back of the repair off, hand sutured and possibly nicked ureter.¿ on (b)(6) 2019, the patient underwent a transvaginal closure of a rectovaginal fistula.On (b)(6) 2019, she underwent yet another repair of the rectovaginal fistula, but the doctor allegedly cut her bladder and she had a segmental small bowel resection, cystorrhaphy, appendectomy, and a diverting loop ileostomy.¿.

Manufacturer Narrative

(b)(4).Date sent: 06/18/2020.Additional information received: medical records.

Manufacturer Narrative

(b)(4).Date sent: 06/18/2020.Additional information received: medical records.

Manufacturer Narrative

(b)(4).Date sent: 11/05/2020.Additional information received.Please see the medical records; op report and path report.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10020797
• MDR Text Key: 194697501
• Report Number: 3005075853-2020-02476
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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
• Date Manufacturer Received: 11/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention