MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) RESECTOSCOPE, WORKING ELEMENT

Model Number	86592351
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4) (rw(b)(4)) (manufacturer).
Event or Problem Description
Richard wolf (b)(4) (rw(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.Working element (id #(b)(6)) (mdr 9611102-2018-00007); outer sheath (id #(b)(6)) (mdr 9611102-2018-00006).Working element manufactured on 17oct2017 with a batch size of 5 units.Sheath was purchased by facility on (b)(6) 2017.
Additional Manufacturer Narrative
(b)(4).Rw(b)(4) considers this case closed.Should additional information become available a follow up report will be submitted.(b)(4).
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) received additional information from richard wolf (b)(4) on june 27, 2018.At this time, the working element and sheath are suspect devices and a report will be submitted for each device.1) outer sheath (id #8659071) (mdr 9611102-2018-00006).2) working element (id #86592231) (mdr 9611102-2018-00007).

• Brand Name: RESECTOSCOPE, WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7367700
• Report Number: 9611102-2018-00007
• Device Sequence Number: 1007037
• Product Code: FDC
• UDI-Device Identifier: 04055207028117
• UDI-Public: 04055207028117
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: No Information
• Device Model Number: 86592351
• Device Catalogue Number: 86592351
• Device Lot Number: 1353412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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