ECHELON ENDOPATH STAPLER
Report
- Report Number
- 3005075853-2025-09552
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- November 20, 2025
- Report Date
- April 7, 2026
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). DATE SENT: 3/30/2026.
(B)(4). DATE SENT: 12/22/2025. ADDITIONAL INFORMATION RECEIVED: NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR.
PRODUCT COMPLAINT #(B)(4). ADDITIONAL INFORMATION RECEIVED: FULL ARTICLE RECEIVED WITH TITLE RISK FACTORS FOR VASCULAR OOZING OR BLEEDING FOLLOWING TRANSECTION WITH AUTOMATIC STAPLERS DURING UNI PORTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY. N=46; EXHIBITED A GRADE 2 OR HIGHER BLOOD LEAKAGE. TREATMENT: HEMOSTATIC INTERVENTION. N=5; GRADE 3 LEAKAGES INVOLVING THE DISTAL PULMONARY VEIN. TREATMENT: LIGATION OF THE DISTAL PULMONARY VEIN TO FACILITATE SURGICAL PROGRESSION.
(B)(4). DATE SENT: 12/16/2025. 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 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. 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.
IT WAS REPORTED VIA JOURNAL ARTICLE: [email protected]. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MOTOYAMA H, ADACHI T, NAKANISHI T, TAKEHARA R, OMASA M. RISK FACTORS FOR VASCULAR OOZING OR BLEEDING FOLLOWING TRANSECTION WITH AUTOMATIC STAPLERS DURING UNIPORTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY. GEN THORAC CARDIOVASC SURG. 2025 NOV 20. DOI: 10.1007/S11748-025-02218-Y. EPUB AHEAD OF PRINT. PMID: 41264190. THE AIM OF THIS STUDY IS TO INVESTIGATE THE RISK FACTORS FOR VASCULAR OOZING OR BLEEDING AFTER VESSEL TRANSECTION WITH AUTOMATIC STAPLERS DURING UNIPORTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS). BETWEEN DECEMBER 2018 AND DECEMBER 2023, 117 CASES (446 TRANSECTED VESSELS) UNDERWENT VESSEL TRANSECTION WITH AUTOMATIC STAPLERS DURING UNIPORTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY USING POWERED ECHELON FLEX® 7 (ETHICON). REPORTED COMPLICATIONS ARE: N=? BLOOD LEAKAGE. TREATMENT: NOT REPORTED. IN CONCLUSION, THIS STUDY IS THE FIRST TO REPORT THAT SHORT STATURE AND LEFT UPPER LOBE VESSELS ARE RISK FACTORS FOR GRADE = 2 BLOOD LEAKAGE DURING UNIPORTAL VATS. ALTHOUGH GRADE 2 BLEEDING IS NOT CRITICAL, IT MAY SERVE AS A PRECURSOR TO GRADE 3 OR MORE SEVERE BLEEDING. THEREFORE, SURGICAL PROCEDURES SHOULD BE PERFORMED WITH CAREFUL CONSIDERATION OF THESE POTENTIAL RISKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269050 | ECHELON ENDOPATH STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |