MAUDE Adverse Event Report: RICHARD WOLF GMBH; INNER SHEATH RESECTOSCOPE 22 FR

Model Number	86753225
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
It was reported to richard wolf by the user facility that: "tip broke off during procedure causing bleeding to the patient.This happened on (b)(6) 2021.Facility has the sheath to do a risk management assessment of the item." other supplied information: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? unknown.The lot number of the device is unknown at this time.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation/product history has been completed and/or new information becomes available.We have reached out the user facility several times already, should we receive a response a follow-up report will be submitted.Thie follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 9/15/2021 we have not received a response.
Event or Problem Description
The purpose of this report is to report additional details about the device malfunction to the fda.Details provided by the sales rep: the sheath is with risk management, so won't be available to send in.Patient is male.The ceramic tip was broken in a couple of pieces during the turp.Time was taken to recover pieces and search for any residual.Unknown at what point breakage occurred.A second set was opened to gain hemostasis and finish case.No further information provided.On 9/10/2021 richard wolf received a medwatch report (mw5103474) from the fda that states "while performing a transurethral resection of the prostate, the inner green sheath broke, irrigation and probing were required to retrieve the broken pieces.Per operating room, this had occurred a few time, therefore we decided to report the event.".
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #2 is to provide fda with new information (product history evaluation) and any changed information.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 07/26/2018, rwmic has not received a response.New information: the following fields have new information: product history evaluation by manufacturer (h10), h6, h8.Changed information: the following fields have changed information: d9/h3 (device not returned).Because the device was not returned by the hospital, the manufacturer (rw gmbh) reviewed the product history for this part number.This is their report: the batch number of the reported device is unknown, a complete ohr review of the reported device is not possible.The complaint database between 08/2019 and 08/2021 was reviewed about the product type 86753225.Rwmic has received 7 complaints: (b)(4)[current complaint].These are documented in the "21-00312 product history trend report".Rwgmbh has received one complaint about the product type 86753225 during the review period of 08/2019 to 08/2021, the current complaint: (b)(4).The device of the complaint (b)(4) won't be returned for investigation neither to rwmic or rwgmbh.The root cause of the damage cannot be determined.However, such damages can occur from physical force due to the limited strength of the device.Also, the product labeling (ga-d366-us /en/ 2017-02 v4.0 / eco 2016-0202) contains adequet warnings and cautions to mitigate the risk of injury to the patients, users and other persons.Another source of possible damages of the ceramic tip, if the hf instruments or lasers are not visible through the scope.If these are activated while they are not visible, inadvertent tissue damage as well as damage to the distal end of the endoscope and the instrument parts is possible.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.
Event or Problem Description
The purpose of this report is to share the results of the product history evaluation with the fda.See manufacturers narrative.

• Brand Name: NA
• Common Device Name: INNER SHEATH RESECTOSCOPE 22 FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12377960
• Report Number: 1418479-2021-00040
• Device Sequence Number: 3662053
• Product Code: FJL
• UDI-Device Identifier: 04055207065464
• UDI-Public: 04055207065464
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

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 Model Number: 86753225
• Device Catalogue Number: 86753225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 04/25/2022
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/15/2021; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male