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

Model Number	86753245
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf received a medsun/medwatch report from the fda: the description event or problem: midway through the turbt (trans urethral resection of bladder tumor) the doctor noticed there was a piece missing from the end of the 26 french sheath from the wolf tur kit.It is unknown whether the sheath was damaged prior to the start of the case or if the piece chipped off during the case.Several x-rays were taken by the doctor in or 17, none of which revealed a visible piece in the patient.The patient was internally examined using a cystoscope and again no pieces were noticed to be left in the patient.Additional information" will the device be returned? according to the medwatch repor initiator, the device was returned on 3 may 2021.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? no.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? none was reported in the medwatch report.Did the delay put the patient at risk? none was reported in the medwatch report.Was there a similar back-up device available for use? unknown.Was the scheduled procedure completed? yes.Correspondence with the user facility the user facility was contacted on 2/7 and 2/9, response received on 2/11/2022.The user facility confirmed that the cystoscopy was done during the patients initial procedure.A second email was sent to the user facility asking if (b)(6) knew what the product and serial number of the resectoscope that malfunctioned.According to her response on 2/14/2022, no record is available.Correspondence with the sales rep email sent to the sales rep asking if there had been a delay or was the procedure prolonged: his response: the x ray prolongs the case.The turbt was over.The cystoscope is already in their set so that wouldn't cause a delay retrieving it.Additional comments: good evening (b)(6) , i hope you are doing well.This is the forwarded email correspondence with (b)(6) from (b)(6) hospital.She mentions that the device was picked up and returned the sheath back to richard wolf medical.I was not in the procedure.The customer wasn't even sure if the continuous flow sheath was broken before the procedure even began.A full cystoscopy examination would have located it.I did not think much of it.Ceramic / porcelain resectoscope inners sheaths are made of non-electrical conductive materials and are not as robust as stainless steel or the titanium inner sheaths.Details from email (5/24/2021) between sales rep and user facility: i know i gave this device to (b)(6) on 5/3.I was also going to report this to med sun.Do you know where i'd be able to get more info re: lot #, serial #, model #, etc? is this something you have on your end? original email from user facility (4/30/2021): as discussed, we had noticed there was a piece missing from the end of the 26 french sheath from the wolf tur kit.It is unknown whether the sheath was damaged prior to the start of the case or if the piece chipped off during the case.Procedure date: (b)(6) 2021.
Additional Manufacturer Narrative
Rwmic is submitting this report for the manufacturer richard wolf gmbh.Rw gmbh considers this mdr open.Rw gmbh will submit a follow up report when new information becomes available.
Additional Manufacturer Narrative
Follow-up report #2 is to provide fda with results of the device investigation.Rw gmbh considers this mdr closed.Should new information be received, a follow-up report will be submitted.
Event or Problem Description
The purpose of this report is to share the results of the device investigation: according to the investigation report, the device was visually tested.It was found "damage is consistent with a single hard impact with a solid object (heavy tool, edge of a table, floor, etc) or frequent lighter impacts.The exact cause cannot be determined without a more detailed history of the sheath's usage." probable root cause: user error.Reported condition was confirmed, the device was repaired.

• Brand Name: SHARK INNER SHEATH
• Common Device Name: INNER SHEATH, RESECTOSCOPE 24 FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13548593
• Report Number: 9611102-2022-00005
• Device Sequence Number: 5023782
• Product Code: FJL
• UDI-Device Identifier: 04055207065471
• UDI-Public: 04055207065471
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86753245
• Device Catalogue Number: 86753245
• Device Lot Number: 1389471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White