ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
Report
- Report Number
- 2210968-2025-07925
- Event Type
- Injury
- Date Received
- July 7, 2025
- Date of Event
- December 12, 2024
- Report Date
- July 7, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAT
- PMA / PMN Number
- K946173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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 NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J ROBOT SURG. 2024 DEC 12;19(1):24. HTTPS://DOI.ORG/10.1007/S11701-024-02182-4. PMID: 39666123.
TITLE: UNDERSTANDING FUNDAMENTAL DIFFERENCES IN SYMPTOMATIC OUTCOMES OF HIATAL VERSUS PARAOESOPHAGEAL HERNIA ROBOTIC REPAIRS. THE AIM OF THIS STUDY IS TO DETERMINE THE DIFFERENCES IN CLINICAL OUTCOMES WHEN COMPARING ROBOTIC-ASSISTED SURGICAL REPAIR OF HIATAL HERNIA (HH) VERSUS TYPES II¿IV PARAOESOPHAGEAL HERNIAS (PEH). BETWEEN AUGUST 2018 AND JUNE 2024, A TOTAL OF 602 CONSECUTIVE PATIENTS UNDERGOING ROBOTIC ASSISTED SURGERY, 254 PATIENTS UNDERWENT HH REPAIR, AND 348 PATIENTS UNDERWENT PEH REPAIR. AGE : HH (56.4 PLUS OR MINUS 10.8), PEH (61.8 PLUS OR MINUS12.7); SEX (M/F) : HH (120 (47.2)/134 (52.8)), PEH (154 (44.3) /194 (55.7)). THE DIAPHRAGMATIC HIATUS IS CLOSED PRIMARILY WITH PLEDGET-REINFORCED 0 ETHIBOND EXCEL SUTURE (ETHICON) SUTURE FOR A TENSION FREE REPAIR. REPORTED COMPLICATIONS ARE -CAPNOTHORAX (N=23) -ESOPHAGEAL HEMATOMA (N=1) -DIAPHRAGM HEMATOMA (N=1) -POSTERIOR VAGOTOMY (N=1) -LIVER LACERATION (N=1) -BILATERAL PULMONARY EMBOLI (N=1) IN CONCLUSION, HHS AND PEHS ARE TWO DISTINCT ENTITIES WHICH MAY BOTH PRESENT WITH REFLUX SYMPTOMS; HOWEVER, DYSPHAGIA IS MORE SPECIFIC TO PEHS. ROBOTIC-ASSISTED REPAIR CAN BE SAFELY PERFORMED IN BOTH HH AND PEH GROUPS. THIS STUDY PROVIDES INSIGHT INTO THE FUNDAMENTAL DIFFERENCES AND SIMILARITIES IN SURGICAL OUTCOMES BETWEEN HIATAL AND PARAOESOPHAGEAL HERNIA ROBOTIC REPAIRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11982 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |