MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2026-01288
- Event Type
- Injury
- Date Received
- February 3, 2026
- Date of Event
- November 24, 2025
- Report Date
- February 3, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- GAN
- PMA / PMN Number
- K960653
- 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: HTTPS://DOI.ORG/10.1080/20905998.2025.2596537.
TITLE: EARLY CONTINENCE ASSESSMENT IN RETZIUS SPARING ROBOT ASSISTED RADICAL PROSTATECTOMY USING CMR VERSIUS ROBOTIC SURGICAL SYSTEM. THE AIM OF THIS STUDY IS TO EVALUATE FUNCTIONAL OUTCOMES, PARTICULARLY CONTINENCE, FOLLOWING RS-RARP PERFORMED USING THE VERSIUS ROBOTIC SURGICAL SYSTEM (CAMBRIDGE MEDICAL ROBOTICS, CMR SURGICAL LTD., CAMBRIDGE, UK), ONE OF THE NEWER ROBOTIC PLATFORMS INTRODUCED INTO UROLOGIC PRACTICE. BETWEEN DECEMBER 2023 TO AUGUST 2024, A TOTAL OF 50 PATIENTS WHO UNDERWENT RETZIUS-SPARING ROBOT-ASSISTED RADICAL PROSTATECTOMY (RS-RARP) USING THE VERSIUS ROBOTIC SURGICAL SYSTEM. THE INCISION WAS THEN CLOSED IN LAYERS USING 0-VICRYL FOR THE EXTERNAL OBLIQUE FASCIA AND 3¿0 MONOCRYL FOR THE SKIN. REPORTED COMPLICATIONS ARE N=2; INTRAPERITONEAL URINE LEAKAGE (CLAVIEN-DINDO CLASS I) TREATMENT: CONSERVATIVE MANAGEMENT N=2; ACUTE URINARY RETENTION (CLAVIEN-DINDO CLASS I) TREATMENT: TEMPORARY CATHETERIZATION FOR 14 DAYS N=1; URETHRORECTAL FISTULA (CLAVIEN-DINDO CLASS IIIB) TREATMENT: SURGICAL REPAIR N=1; VERY SEVERE INCONTINENCE TREATMENT: UNDERWENT A MALE SLING PROCEDURE VIA A PERINEAL INCISION. IN CONCLUSION, RS-RARP USING THE VERSIUS ROBOTIC SURGICAL SYSTEM IS FEASIBLE AND DEMONSTRATES FAVORABLE EARLY OUTCOMES IN TERMS OF CONTINENCE, POTENCY, AND ONCOLOGICAL SAFETY. FURTHER STUDIES WITH LARGER COHORTS AND EXTENDED FOLLOW-UP ARE WARRANTED TO VALIDATE THESE FINDINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310642 | MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT | SUTURE, ABSORBABLE, SYNTHETIC | GAN | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |