MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) OUTER SHEATH RESECTOSCOPE

Model Number	8659071
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation/evaluation currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).
Event or Problem Description
Richard wolf (b)(4) ((b)(4)) was notified by user facility that during a procedure the tip of the sheath broke into pieces and fell into the patient.Pieces were recovered from patient.Facility also reported burn marks on the working element and damaged electrode.At this time, the working element and sheath are suspect devices and a report will be submitted for each device.1) working element (id #(b)(4)) (mdr 9611102-2018-00007); 2) outer sheath (id #(b)(4)) (mdr 9611102-2018-00006).Sheath manufactured on 18oct2017 with a batch size of (b)(4) units.Sheath was purchased by facility on (b)(4) 2017.
Additional Manufacturer Narrative
Additional information: richard wolf medical instruments corporation attempted to obtain the required fields from the user facility on 3 different occasions: (b)(4) 2018 however, no response was received.Richard wolf mic considers this matter closed, however, should additional information become available, a follow up will be submitted as required.

• Brand Name: OUTER SHEATH RESECTOSCOPE
• Common Device Name: SHEATH
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7367694
• Report Number: 9611102-2018-00006
• Device Sequence Number: 1373730
• Product Code: FJL
• UDI-Device Identifier: 04055207019078
• UDI-Public: 04055207019078
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K982677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018
• Report Date (Section F): 08/09/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 8659071
• Device Catalogue Number: 8659071
• Device Lot Number: 1360825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTING CABLE; ELECTRODE; FOOTSWITCH; GENERATOR; INNER SHEATH
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 08/09/2018