ECHELON ENDOPATH STAPLER
Report
- Report Number
- 3005075853-2025-04947
- Event Type
- Injury
- Date Received
- July 1, 2025
- Date of Event
- July 19, 2021
- Report Date
- July 1, 2025
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
(B)(4). DATE SENT: 7/1/2025. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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 FILED AS APPROPRIATE.
TITLE: COLORECTAL CANCER SURGERY: BY CAMBRIDGE MEDICAL ROBOTICS VERSIUS SURGICAL ROBOT SYSTEM¿A SINGLE-INSTITUTION STUDY. OUR EXPERIENCE. AUTHOR: SHAILESH P. PUNTAMBEKAR, K. N. RAJESH, ARJUN GOEL, MANGESH HIVRE, SUYOG BHARAMBE, MIHIR CHITALE, MANGESH PANSE. CITATION: JOURNAL OF ROBOTIC SURGERY (2022) 16:587¿596 HTTPS://DOI.ORG/10.1007/S11701-021-01282-9. THE AIM OF THE STUDY IS A PROSPECTIVE ANALYSIS AND EVALUATION OF SHORT-TERM RESULTS OF CONSECUTIVE PATIENTS TO STUDY THE TECHNICAL FEASIBILITY AND ONCOLOGICAL OUTCOME OF ROBOT-ASSISTED LOW ANTERIOR RESECTION (LAR) AND ULTRALOW ANTERIOR RESECTION (ULAR), USING THE CMR VERSIUS SURGICAL ROBOT SYSTEM. THIS STUDY WAS CONDUCTED AT SINGLE MINIMAL ACCESS SURGERY INSTITUTE. 31 PATIENTS WITH COLORECTAL ADENOCARCINOMA UNDERWENT ROBOT-ASSISTED LAR AND ULAR BETWEEN AUGUST 2019 AND MARCH 2020. 23 WERE MEN AND 8 WOMEN, WITH MEAN AGE OF 55.6 YEARS. 2/0 VICRYL SUTURE (ETHICON), ECHELON 60 BOWEL STAPLER (JOHNSON AND JOHNSON, USA) , CCD 33 MM CIRCULAR STAPLER ANVIL (JOHNSON AND JOHNSON, USA), PROLENE 2¿0 (ETHICON), REPORTED COMPLICATIONS INCLUDED ILEUS (N=2), SURGICAL SITE INFECTION (N=3), ANASTOMOTIC DEHISCENCE (N=1). IN CONCLUSION THE CMR VERSIUS ROBOT HAS ALL THE QUALITIES IN TERMS OF DEXTERITY, VISION AND INTUITIVE MOVEMENTS. THE MOST IMPORTANT ADVANTAGE IS TO TRANSLATE THIS TECHNICAL ABILITY INTO ONCOLOGICAL SAFETY. THE QUALITY OF TME ACHIEVED IS COMPARABLE TO THAT OF LAPAROSCOPY. THE SAME ROBOTIC PORTS CAN BE USED FOR THE LAPAROSCOPIC INSTRUMENTS. THE MOBILE ARMS OF THE ROBOTIC SYSTEM ARE AN ADDED ADVANTAGE OF THIS SYSTEM. THE SHORT-TERM RESULTS ARE PROMISING IN TERMS OF MORBIDITY AND TIME TO DISCHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1357538 | ECHELON ENDOPATH STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |