RELOAD FOR 60MM ECHELON
Report
- Report Number
- 3005075853-2021-06369
- Event Type
- Injury
- Date Received
- October 22, 2021
- Date of Event
- January 11, 2016
- Report Date
- September 11, 2023
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- UDI-DI
- 10705036014362
- PMA / PMN Number
- K051002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). DATE SENT: 11/4/2021. ADDITIONAL INFORMATION: PER THE PATIENT: HARMED BY ETHICON ECHELON STAPLER BLACK ECR60T. STOMACH REMOVED AFTER LEAK COULD NOT BE STOPPED. LUNG REMOVED AND SPLEEN. NOW I HAVE LEUKEMIA. BECAUSE OF THE STAPLER.
(B)(4). DATE SENT: 1/6/2023. SEE ATTACHED OP REPORT.
(B)(4). DATE SENT: 1/6/2023. SEE ATTACHED OP REPORT.
(B)(4). DATE SENT: 1/6/2023. SEE OP REPORT.
(B)(4). DATE SENT: 1/6/2023. SEE ATTACHED OP REPORT.
(B)(4). DATE SENT: 1/6/2023. SEE ATTACHED OP REPORT.
(B)(4). DATE SENT: 1/6/2023. SEE ATTACHED OP REPORT.
(B)(4). DATE SENT: 9/11/2023. ADDITIONAL INFORMATION WAS OBTAINED: "I HAD ENDOSCOPIC GASTRIC SLEEVE SURGERY. SURGEON USED ETHICON ECHELON ENDOCUTTER BLACK MODEL ECR60T. I HAD STAPLE LINE LEAK AND ENDED UP HAVING THREE ORGANS REMOVED AND NOW HAVE LEUKEMIA. I DIDN'T KNOW THE PRODUCT WAS ON A FDS RECALL.¿ ADDITIONAL INFORMATION WAS OBTAINED: UNKNOW INDIVIDUAL REQUESTING HELP AND INDICATING THEY HAD BEEN HARMED BY THE PRODUCT CLEARED IN K131663. INDIVIDUAL SENDING EMAIL INCLUDED A PHONE NUMBER: ((B)(6)AND AN EMAIL ADDRESS: (B)(6), AND A PDF OF CLEARANCE K131663. FULL MESSAGE READS: SUBJECT: PLEASE HELP HI THERE. I WAS HARMED BY THIS MEDICAL DEVICE. I NEED THE LOT NUMBER. CAN YOU HELP? THANK YOU (B)(6).
(B)(4). MEDICAL DEVICE: BATCH # UNK. DATE OF EVENT: UNKNOWN; CAPTURED AS AWARENESS DATE. 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. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED: SPOKE WITH PATIENT LAST WEEK WHO INITIALLY INDICATED SHE WAS UNWILLING TO PROVIDE ANY ADDITIONAL DETAIL. SHE EVENTUALLY SHARED THAT THE HOSPITAL WAS (B)(6) REGIONAL MEDICAL CENTER AND THAT THEY ARE NO LONGER IN BUSINESS AND HAD NO DETAILED INFORMATION. HER SURGEON WAS (B)(6) MD AND THE SURGERY WAS IN (B)(6) 2016. EXPLAINED THE SUPPLY CHAIN PROCESS AND HIPAA REQUIREMENTS AND WHY THE LOT NUMBER FOR ANY DEVICE USED IN HER SURGERY WOULD NEED TO COME FROM THE HOSPITAL OR POSSIBLY THE THIRD PARTY DISTRIBUTOR, (B)(4). A PHONE NUMBER FOR (B)(4) WAS PROVIDED AND SHE WAS PLANNING TO FOLLOW UP WITH THEM DIRECTLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT THE PATIENT HAD SURGERY IN 2016. SHE WAS INQUIRING ABOUT ECR60T WHICH WAS USED IN HER SURGERY AND WANTED TO KNOW WHICH LOT NUMBER SHE HAS IMPLANTED IN HER. PATIENT STATES THAT SHE HAS SINCE HAD TO HAVE HER STOMACH REMOVED AND IS VERY SICK. PATIENT STATES THAT SHE IS A SINGLE MOM, HAS CANCER AND IS VERY SICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1583037 | RELOAD FOR 60MM ECHELON | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | K4CG8P | 10705036014362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |