MAUDE Adverse Event Report: RICHARD WOLF GMBH INTERNAL SHEATH RESECTOSCOPE

Model Number	8675322
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic has requested additional and missing information from the user facility and the manufacturer of the device.Upon receipt of the information, rwmicwill submit a follow-up report as appropriate.Rwmic considers this case open.
Event or Problem Description
Richard wolf medical instruments corporation, hereinafter referred to as rwmic, was notified via rwmic sales team of an event that occurred during patient procedure on an unspecified date.It was reported that the ceramic tip broke off and fragmented into the patient.The customer reported that this occurred when using a green light laser.The surgeon removed the pieces.There was no adverse outcome to the patient.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.
Event or Problem Description
Follow up #2 to report new information to fda.
Event or Problem Description
User facility returned the device to richard wolf medical instruments corporation (rwmic) on (b)(6) 2018 and the evaluation was completed on (b)(6) 2018.The device appeared to be used, broken, and the o-ring was noted to be worn out.The device was visually evaluated and the reported complaint condition was verified - the ceramic tip was noted to be broken.It is suspected that the tip may have been cracked during reprocessing which may have led to the tip breaking during use.A manufacturing defect was not identified.The device was repaired.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: the user facility was contacted in an effort to collect additional information, but no additional information could be provided.New information: changed information: the following fields have changed information: f3-5, h3 device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed and the following cautions, checks, and warnings were identified: caution! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.Caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Caution! be careful if products are damaged or incomplete! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Visual check -check products and accessories for damage, sharp edges, loose or missing parts and rough surfaces.Check the insulation with particular care.Warning! danger of injury! incorrect handling, e.G.Fall, shock, blows or similar mechanical loads can cause hair cracks and / or spalling of the ceramic coating in the distal area of the resectoscope sheath.Injuries of the patient, user or third parties are possible.Mind surface changes and ensure safe handling.Do not use damaged resectoscope sheaths, return damaged sheaths for repair.Check the ceramic insulation at the distal end of the resectoscope sheath for damage before every use.Important! careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products.Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.

• Brand Name: INTERNAL SHEATH RESECTOSCOPE
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7835343
• Report Number: 1418479-2018-00022
• Device Sequence Number: 11124062
• Product Code: FJL
• UDI-Device Identifier: 04055207019641
• UDI-Public: 04055207019641
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• 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,Followup
• Report Date (Section B): 08/06/2018
• Report Date (Section F): 03/12/2019

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 Model Number: 8675322
• Device Catalogue Number: 8675322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/06/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 11/16/2018; 03/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 03/12/2019