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

Model Number 86592351

Device Problems Thermal Decomposition of Device (1071); Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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.

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 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
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7367700
• MDR Text Key: 103689555
• Report Number: 9611102-2018-00007
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028117
• UDI-Public: 04055207028117
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONNECTING CABLE; ELECTRODE; FOOTSWITCH; GENERATOR; INNER SHEATH
• Patient Outcome(s): Other