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 Problems Pain (1994); Uterine Perforation (2121); Blood Loss (2597)

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: gynecological surgery.Conference: 22nd annual congress of the european society of gynaecological endoscopy, esge 2013.Berlin germany.Conference publication: (var.Pagings).10 (suppl.1) (pp s123), oct 2013.(b)(4).

Event Description

Title: complications of diagnostic hysteroscopy.5 year's experience in a teaching hospital the aim of this study is to describe the incidence and treatment of complications during the 4363 diagnostic hysteroscopy procedures made in hysteroscopy unit, university hospital princice asturias, madrid, spain.From 2009 to june 2013, data from a total of 4363 cases of diagnostic hysteroscopy performed were collected and analyzed the 476 cases in which complications occurred.Versapoint (ethicon) with other devices (grasping forceps, hyteroscopic scissors) were used as surgical supplies depending on the case.Complaint included major bleeding (n=22) where one procedure was suspended, uterine perforation (n=6), false passage (n=8), and mild pain (n=?).The results presented that diagnostic hysteroscopy is a generally safe procedure.The complications are often mild, if the safety criteria established for technique are followed.The surgeon¿s experience also minimizes the risk.

• 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: 9241153
• MDR Text Key: 167208811
• Report Number: 2210968-2019-89062
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• 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