MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARKS/S-LINE; CUTTING ELECTRODE BIPO 24FR 12/30°

Model Number	4622.1313
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility will be contacted again to obtain additional information.A follow up will be submitted upon receipt of additional information and/or completion of device evaluation.Rwmic considers this case open.
Event or Problem Description
On august 22, 2019, richard wolf medical instruments corporation (rwmic) received voluntary event report (mw5088816).It was reported that an electrocautery loop broke during a procedure.The hospital staff was unable to determine if all the pieces were still present.The surgeon did a visual inspection to examine the entry and to locate any missing pieces.None were found or visualized.

• Brand Name: SHARKS/S-LINE
• Common Device Name: CUTTING ELECTRODE BIPO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9100884
• Report Number: 1418479-2019-00047
• Device Sequence Number: 16808377
• Product Code: JOS
• UDI-Device Identifier: 04055207048856
• UDI-Public: 04055207048856
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2019
• Report Date (Section F): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 4622.1313
• Device Catalogue Number: 4622.1313
• Device Lot Number: 51015519
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: Required Intervention
• Date Report Sent to FDA: 09/20/2019