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 Uterine Perforation (2121)

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: fertil steril.2009; 91: 1273¿8.Doi: 10.1016/j.Fertnstert.2008.01.083.(b)(4).

Event Description

It was reported in a journal article with title: a randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (tcris, versapoint) using saline, in hysteroscopic surgery the objectives of this randomized study was to compare three types of equipment during hysteroscopic resection.This study consist of 200 premenopausal women with menorrhagia caused by dysfunctional bleedings, fibroids, or polyps.Of which, 64 patients were randomized under the monopolar group (age: 44.9 ± 5.1), 71 patients in the tcr group (age: 43.2 ± 5.0), and 65 patients in the gynecare versapoint (ethicon) group (age: 44.6 ± 5.0).In the gynecare versapoint group, reported complications included lack of sterilized equipment (n-1) which lead to exclusion after randomization, technical problems during the procedure (n-4) which led to change of equipment and exclusion after randomization , and perforation (n-1).In conclusion, the results suggest that hysteroscopic resection in saline has an improved safety profile compared with resection in glycine 1.5%, because of the absence of reduction in serum sodium after intravasation.Although the authors observed more fluid deficit in the two saline groups, the authors did not observe any side effects.The tcris appears to be as effective as the monopolar equipment, concerning operating time and tissue removed.

• Brand Name: VERSAPOINT ELECTRODE UNKNOWN PRODUCT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1210 ward avenue; west chester PA 19380
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 9160327
• MDR Text Key: 166951747
• Report Number: 2210968-2019-88402
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/06/2019
• 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