ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
Report
- Report Number
- 2210968-2026-02860
- Event Type
- Injury
- Date Received
- March 20, 2026
- Date of Event
- September 23, 2025
- Report Date
- March 20, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- GAT
- PMA / PMN Number
- K946173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- 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. 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: OBES SURG. 2025 DEC;35(12):5625-5629. HTTPS://DOI.ORG/10.1007/S11695-025-08303-8 EPUB 2025 OCT 27. PMID: 41144145; PMCID: PMC12722364.
TITLE: STRANGULATED DIAPHRAGMATIC HERNIA FOLLOWING ROUX-EN-Y GASTRIC BYPASS: SURGICAL PITFALLS AND LESSONS LEARNED. THIS STUDY PRESENTS THE CASE OF A 36-YEAR-OLD FEMALE WITH AN UNREMARKABLE MEDICAL HISTORY WHO UNDERWENT ROUX-EN-Y GASTRIC BYPASS (RYGB). ONE YEAR LATER, THE PATIENT BEGAN TO REPORT RECURRENT EPISODES OF VAGUE ABDOMINAL PAIN. INVESTIGATIONS REVEALED CALCULOUS GALLBLADDER DISEASE. THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION AND RESECTION OF THE STRANGULATED SEGMENT OF THE TRANSVERSE COLON WAS PERFORMED. A CONCOMITANT HIATUS HERNIA WAS DETECTED AND REPAIRED WITH A CRUROPLASTY AND ESOPHAGOPEXY USING ETHIBOND (ETHICON, SOMERVILLE, NJ, USA). REPORTED COMPLICATIONS ARE: 36-YEAR-OLD FEMALE PATIENT, ETHIBOND, DIFFICULTY BREATHING AND LEFT-SIDED PLEURITIC CHEST PAIN, TREATMENT: TAPPING WAS DONE TWICE, LEFT THORACIC EFFUSION COMPLETELY OCCLUDING THE LEFT LUNG, TREATMENT: TAPPING WAS DONE TWICE. IN CONCLUSION, IATROGENIC DIAPHRAGMATIC HERNIA IS A RARE AND POTENTIALLY FATAL CONDITION. DIAGNOSIS CAN BE CHALLENGING DUE TO THE VAGUE PRESENTATION, WHICH MAY BE ATTRIBUTED TO MORE COMMON CONDITIONS. EARLY DIAGNOSIS AND PROPER SURGICAL INTERVENTION CAN HELP TO AVOID MORBIDITIES, IF NOT MORTALITY. CAREFUL HANDLING OF ENERGY DEVICES NEAR THE DIAPHRAGM, ALONG WITH AWARENESS OF THE POTENTIAL FOR IATROGENIC DIAPHRAGMATIC HERNIA AFTER BARIATRIC SURGERIES, IS NECESSARY TO AVOID THIS POTENTIALLY FATAL CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715764 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Required Intervention |