MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 24FR

Model Number	8675324
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Richard wolf medical instruments corporation is submitting this report on behalf of richard wolf gmbh (manufacturer).The 8675324 internal sheath resectoscope 24fr has been in the programme since 07/16/2014.The internal sheaths with the batch number 1468281 were booked on 02/02/2021 with a total quantity of 15 pieces on the new goods stock.A total of 9 pieces were delivered to the distributor in italy on 03/18/2021.According to the production record, no indications of product or production defects are apparent.The instrument has to remain in the user facility for at least 30 days because of the user notification, so the instrument was not yet been received for examination.As soon as the examination is completed, rw gmbh will send a follow-up report.
Event or Problem Description
Rwgmbh reference complaint no.(b)(4).Richard wolf gmbh in knittlingen (manufacturer) was informed about a user notification to the italian competent authority via distributor.Description of incident/claim: during a thulep procedure, a component of the bipolar resectoscope was apparently lost in the patient, but this was only noticed after the procedure was completed.The patient therefore had to undergo another minimally invasive surgery 3 days later to have the foreign body removed.This case was reported by the user to the italian authorities.Rwgmbh mdr awareness date: 23-sept-2022.
Additional Manufacturer Narrative
The following fields have new information: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), h7, and h10.The internal sheath resectoscope 24fr 8675324 was investigated in the responsible department.Upon investigation, it was found that the ceramic tip was broken off and is missing.The remaining ceramic fragment in the sheath is glued and still preserved.Apart from that, no other damage is visible.A breakage of the ceramic tip is not to be expected when the device is used as intended, as only low forces are applied during endoscopic use.Such fractures are primarily due to mechanical influences, which can be caused by falling or impact damage.The internal sheath resectoscope 24fr 8675324, batch # 1468281 was manufactured on 02/feb/2021.The batch consisted of 15 pieces.No issues were identified during production, no further complaints were received from the reported batch.The ifu ga-d366-us / en / 2017-02 v4.0 / eco 2016-0202 contains several instructions of visual and functional checks prior and after each use in section 8 checks.Furthermore, the user is advised about the limited strength of the device in section 7 operating instruction.The subject issue of breakage of the tip due to mechanical influence is present in the risk management file d3 - reusable shafts, tubes, rev.04.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 24FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer Contact: philipp schmidt ; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• MDR Report Key: 15587820
• Report Number: 9611102-2022-00054
• Device Sequence Number: 7169555
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1468281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown