VCL CT BRD VIO 27IN 0 S/A CT-1
Report
- Report Number
- 2210968-2022-09775
- Event Type
- Injury
- Date Received
- November 28, 2022
- Report Date
- January 19, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- UDI-DI
- 10705031039032
- PMA / PMN Number
- K022269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(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. (B)(4). DEVICE NOT RETURNED. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AS A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WHAT IS THE ALLEGED DEFICIENCY OF THE SUTURE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. IF THE PATIENT HAS NOT UNDERWENT REOPERATION TO DATE, ARE THERE PLANS FOR THE PATIENT TO UNDERGO REOPERATION? IF YES, IS THERE A SCHEDULED DATE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? PLEASE PROVIDE DATE/NUMBER OF DAYS POST OP THAT THE PATIENT EXPERIENCED URETERAL STENOSIS DUE TO BLADDER SPASM OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER? SURGEON¿S NAME? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY WAS REOPERATION NECESSARY TO REMOVE THE SUTURE AND RE-CLOSE THE WOUND? IF YES. PLEASE PROVIDE SCHEDULED RE-OPERATION'S DATE (MM/DD/YYYY) IF PRODUCT WAS REMOVED, WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE REMOVAL? COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. WHAT IS THE CURRENT STATUS OF THE PATIENT? PLEASE PROVIDE THE LOT NUMBER:
(B)(4) DATE SENT TO THE FDA: 1/19/2023. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE ALLEGED DEFICIENCY OF THE SUTURE?:NOT REPORTED. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE:FEMALE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? :NO FURTHER INFORMATION IS AVAILABLE. ON WHAT TISSUE WAS THE SUTURE USED?:VAGINAL STUMP WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)?:UNKNOWN HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)?:UNKNOWN. HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)?:UNKNOWN PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. :REOPERATION IF THE PATIENT HAS NOT UNDERWENT REOPERATION TO DATE, ARE THERE PLANS FOR THE PATIENT TO UNDERGO REOPERATION? IF YES, IS THERE A SCHEDULED DATE?:-. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION?:UNKNOWN. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE?: URETERAL STENOSIS. PLEASE PROVIDE DATE/NUMBER OF DAYS POST OP THAT THE PATIENT EXPERIENCED URETERAL STENOSIS DUE TO BLADDER SPASM OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS?: UNKNOWN. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?: IT IS POSSIBLE THAT THE BLADDER WAS CAUGHT DURING THE OPERATION OF SUTURING THE VAGINAL STUMP.. WHAT IS THE PATIENT'S CURRENT STATUS?: UNKNOWN. LOT NUMBER?: UNKNOWN. SURGEON¿S NAME? (B)(6) (B)(4)
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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY : THEY PLANNED TO PERFORM REOPERATION TO REMOVE THE SUTURE. WAS REOPERATION NECESSARY TO REMOVE THE SUTURE AND RE-CLOSE THE WOUND? IF YES. PLEASE PROVIDE SCHEDULED RE-OPERATION'S DATE (MM/DD/YYYY) :THE SURGEON IS THINKING ABOUT REMOVING THE SUTURE IN RE-OPERATION IN A FEW DAYS. IF PRODUCT WAS REMOVED, WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE REMOVAL?N/A. COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. UNKNOWN. WHAT IS THE CURRENT STATUS OF THE PATIENT? UNKNOWN. PLEASE PROVIDE THE LOT NUMBER: UNKNOWN.
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2022 AND SUTURE WAS USED ON THE VAGINAL CUFF AND BLADDER. DURING SUTURING OF THE VAGINAL CUFF, THERE WAS A POSSIBILITY THAT THE BLADDER WAS CAUGHT BY A NEEDLE-SUTURE DURING SUTURING. AFTER THE SURGERY, THE URINARY BLADDER WAS CONTRACTED, RESULTING IN STENOSIS OF THE URETER. THE PATIENT HAD URETERAL STENOSIS DUE TO BLADDER SPASM. THERE WAS A DIFFERENCE IN OPINION BETWEEN THE DOCTORS WHO SAY THAT SINCE IT IS ABSORBABLE SUTURE, TANGLES CAN BE RESOLVED BY WAITING FOR ABSORPTION AND THE DOCTORS WHO SAY THAT THE SUTURE SHOULD BE REMOVED BY REOPERATION. IT WAS REPORTED THAT THERE WAS NO POSSIBILITY THAT THE URETER ITSELF WAS DAMAGED AT THIS POINT. FUTURE ACTIONS ARE BEING CONSIDERED. ADDITIONAL INFORMATION WAS REQUESTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2711969 | VCL CT BRD VIO 27IN 0 S/A CT-1 | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | J340H | 10705031039032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |