FDA Adverse Event Injury Summary report: N

UNKNOWN PROTACK

MDR report key: 14365808 · Received May 11, 2022

Report

Report Number: 2647580-2022-01609
Event Type: Injury
Date Received: May 11, 2022
Date of Event: February 8, 2022
Report Date: May 11, 2022
Manufacturer: US SURGICAL PUERTO RICO
Product Code: GCJ
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

TITLE: A ROBOTIC APPROACH TO MANAGEMENT OF FAILED SACROCOLPOPEXY AND SACROCOLPOPEXY COMPLICATIONS: A CASE SERIES SOURCE: INTERNATIONAL UROGYNECOLOGY JOURNAL HTTPS://DOI.ORG/10.1007/S00192-022-05134-4. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 0

ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2014 AND JANUARY 2021, A RETROSPECTIVE CASE SERIES AIMED TO DESCRIBE A ROBOTIC APPROACH IN TREATING THE MANAGEMENT OF FAILED SACROCOLPOPEXY AND SACROCOLPOPEXY COMPLICATIONS IN PATIENTS UNDERGOING ABDOMINAL RE EXPLORATION AFTER INITIAL SURGERY FOR TREATMENT OF PELVIC ORGAN PROLAPSE. NINETEEN PATIENTS WERE IDENTIFIED BY CURRENT PROCEDURE TERMINOLOGY CODES; TEN MET INCLUSION CRITERIA. THERE WAS ONE PATIENT, WHO PRESENTED WITH COMPLAINTS OF IRREGULAR BLEEDING, WAS FOUND TO HAVE A SEROSANGUINOUS FLUID COLLECTION OVERLYING MESH ON ANTERIOR CERVIX WITH COMPETITOR SUTURE, AS WELL AS 5 PROTACKS FROM A PREVIOUS REPAIR. THE PATIENT UNDERWENT A ROBOTIC EXCISION OF MESH, TRACHELECTOMY, UTEREROSACRAL LIGAMENT SUSPENSION WITH CYSTOSCOPY. PATIENT WAS WITHOUT COMPLAINTS 6 MONTHS POST-OPERATIVELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1112580	UNKNOWN PROTACK	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	US SURGICAL PUERTO RICO	UNKNOWN PROTACK

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other