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

Model Number 8680.205

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/11/2019

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.A follow up report will be submitted with the investigation results.

Event 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.

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 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
• Type of Device: WORKING ELEMENT ACTIVE BIPO 0/12/30
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9050559
• MDR Text Key: 158599281
• Report Number: 9611102-2019-00023
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042939
• UDI-Public: 04055207042939
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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