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

Model Number	4622.131
Medical Device Problem Codes	Break (1069); Device Issue (2379)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENT CORPORATION; 353 corporate woods parkway; vernon hills IL 60061 0924
• MDR Report Key: 6396549
• Report Number: 1418479-2017-00003
• Device Sequence Number: 919157
• Product Code: FAS
• UDI-Device Identifier: 04055207048856
• UDI-Public: 04055207048856
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other