MAUDE Adverse Event Report: RICHARD WOLF GMBH; RECTOSCOPE TUBE Ø 19MM WL 211MM

Model Number	8834075
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility representative has informed richard wolf gmbh an issue regarding a rectoscope tube ø 19mm wl 211mm, part id: 8834075, batch # 1446330.According to the received information: "when retracting the rectoscope during examination, the metal end piece came loose and got stuck in the rectum.Removal of the end piece with proctoscope, forceps and needle holder by detaching the end piece.The procedure could not be completed due to defective device." according to the user, there was no harm to the patient.
Additional Manufacturer Narrative
New information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h10.The rectoscope tube ø 19mm wl 211mm 8834075, batch #1446330 was investigated in accordance with the test instructions.The device has severe signs of usage such as dents, bumps and scratches.The metal insulating cap is missing, the user facility did not returned it with the reported device.The root cause of the missing insulating cap is mechanical impacts on the device which may have occurred during transport within the user facility, during preparation prior use, during use or in a combination of these.The rectoscope tube ø 19mm wl 211mm 8834075, batch #1446330 was manufactured on 27/jul/2020.The batch consisted of 8 pieces.No issues were identified during production.No further complaints with the same device issue were received.The ifu ga-f 043 / en / 2013-08 v3.0 / pk18-9297 contains safety instructions about the checks prior and after each use as well as safety notes about use of previously damaged device in section 7 checks.The subject issue of unusable device is present in the risk management file d3: reusable sheaths, tubes, rev.: v00.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: NA
• Common Device Name: RECTOSCOPE TUBE Ø 19MM WL 211MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16644204
• Report Number: 9611102-2023-00020
• Device Sequence Number: 5340239
• Product Code: GCM
• UDI-Device Identifier: 04055207043356
• UDI-Public: 04055207043356
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: PRE-ENAC
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8834075
• Device Catalogue Number: 8834.075
• Device Lot Number: 1446330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown