MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENT CORPORATION S(A)LINE BIPOLA ELECTRODES; ELECTRODE, ELECTROSURGICAL

Model Number 4622.131

Device Problems Break (1069); Device Issue (2379)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

Unable to perform investigation as actual device has not been returned to richard wolf medical instrument corporation.User facility has been contacted on (b)(6) 2017 in an effort to gather missing information as well as to have device be returned for investigation.No injury has been reported.There has been no trend identified for this product type (product i.D.# (b)(4)).Rwmic considers this matter closed.A follow up report will be provided to fda if additional information is received or actual device is returned for investigation.

Event Description

Richard wolf instrument corporation (rwmic) has received a medwatch report (report # (b)(4) ), on (b)(6) 2017.Facility has reported an event where the loop broke off into patient during a hysteroscopy procedure.There was a delay in the procedure in order to retrieve foreign object from patient that may have put the patient at risk.Back up device was used to complete the procedure, after foreign object had been removed.No injury to patient has been reported.

• Brand Name: S(A)LINE BIPOLA ELECTRODES
• Type of Device: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENT CORPORATION; 353 corporate woods parkway; vernon hills IL 60061 0924
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENT CORP.; 353 corporate woods parkway; vernon hills 60061 3110
• Manufacturer Contact: jozsef radovits ; 353 corporate woods parkway; vernon hills, IL 60061-3110 ; 8479558013
• MDR Report Key: 6396549
• MDR Text Key: 69760747
• Report Number: 1418479-2017-00003
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048856
• UDI-Public: 04055207048856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: 4622.131
• Device Catalogue Number: 4622.1313
• Device Lot Number: 51003453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other