MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE RESECTOSCOPE; WORKING ELEMENT ACTIVE BIPO 0/12/30

Model Number	8680.205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/11/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing.A follow up report will be submitted with the investigation results.
Event or Problem Description
On september 11, 2019, richard wolf (b)(4) received the following information: a patient death was reported by the hospital (b)(6) in (b)(6) where an s-line resectoscope working element and accessories were being used during a procedure, transurethral resection of the bladder.The bladder of the patient was reported to have been filled with sodium chloride (nacl) solution.During the resection (not in the ignition phase), the bladder burst and caused a pelvic artery to tear.This happened almost at the end of the surgical procedure.An unsuccessful emergency operation was carried out for over approximately three(3) hours, with four (4) doctors present.The patient expired during the emergency operation.The patient was (b)(6) years old and was in normal, good state of health.There was no information available regarding the quantity of nacl used or about the flushing pressure.The position of the nacl bottle was approximately 1m above the operating table without a pump.It is currently not known how long the resection took.
Additional Manufacturer Narrative
The following fields contain new/changed information: d4, d11, g7, h3, h4, h6, and h10.An investigation was conducted on the s-line resectescope and the conconminant devices.The evaluation results have been attached.Rw gmbh considers this case closed.Should additional information become available, a follow-up will be submitted.
Event or Problem Description
The following devices were being used during the procedure, in conjunction with the working element (s-line resectoscope): cutting electrode bipo 22fr 12/30 °.Panoview-telescope 30 ° ø 4mm nl 300mm.Outer sheath for resectoscope 26fr.Inner sheath resectoscope 24fr.A bladder syringe kit was also used.The hf generator used was a maxium hw6, manufactured by kls martin.Further information about the hf cables and power settings of the generator was not available.The rinsing liquid, nacl 0.9%, 1 l bottle (manufactured by bbraun) was introduced by means of an infusion stand approximately 1 m above the surgical field without a pump via the bipolar resection system into the bladder.

• Brand Name: S-LINE RESECTOSCOPE
• Common Device Name: WORKING ELEMENT ACTIVE BIPO 0/12/30
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9050559
• Report Number: 9611102-2019-00023
• Device Sequence Number: 19396728
• Product Code: FDC
• UDI-Device Identifier: 04055207042939
• UDI-Public: 04055207042939
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8680.205
• Device Catalogue Number: 8680.205
• Device Lot Number: 1420083
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR