MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ELECTRODE UNKNOWN PRODUCT; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number VERSAUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Citation: reproductive sciences 00(0) 1-7, doi: 10.1177/1933719112466308.Reproductive sciences published online 10 december 2012.(b)(4).

Event Description

Title: a multicenter, double-blind, randomized, placebo-controlled study to assess whether antibiotic administration should be recommended during office operative hysteroscopy.This multicenter, double-blind, randomized, placebo-controlled study aimed to assess the incidence of infectious complications and the protective effect of prophylactic antibiotic during operative hysteroscopic procedures in an office setting.Between january and october 2010, a total of 1046 patients undergoing office hysteroscopy during the immediate postmenstrual phase of the menstrual cycle (6th-10th day, computed on the base of the last menstrual period as referred by patients) were included in the study.The patients were randomly assigned to either reference group (n=523; mean age of 36.3 years, mean bmi of 24.8) where 1 g of cefazolin was intramuscularly (im) administered during hysteroscopic procedure; and study group (n=523; mean age of 42.1 years, mean bmi of 26.6), where patients were administered with 10 ml of isotonic sodium chloride solution (the placebo) during hysteroscopic procedure.Operative procedures include polypectomy, synechiolysis, metroplasty, and myomectomy.After panoramic visualization of the entire uterine cavity, the operative procedures were performed with standard techniques using grasping forceps, scissors, and bipolar electrodes (versapoint gynecare, ethicon).Complaints included postsurgical infectious complications (n=12).In details, 7 patients who had complications belong to the study (untreated) group [polypectomy (n=2), synechiolysis (n=1), metroplasty (n=2), myomectomy (n=1), others (n=1)] and 5 from the reference group [polypectomy (n=3), metroplasty (n=1), myomectomy (n=1)].Antibiotics were prescribed in all cases of postsurgical infection and the infective process resolved in few days.The results presented in this study would support the american college of obstetricians and gynecologists recommendation not to prescribe routine antibiotic administration in the case of hysteroscopic surgery, considering the low risk of infectious complications after hysteroscopy.

• Brand Name: VERSAPOINT ELECTRODE UNKNOWN PRODUCT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9239188
• MDR Text Key: 167204583
• Report Number: 2210968-2019-89055
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VERSAUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention