MAUDE Adverse Event Report: COLOPLAST A/S BROOKS DILATOR SET; CORPUS CAVERNOSUM DILATOR, REUSABLE

Catalog Number	91-9350
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.
Event or Problem Description
According to the available information, the 12mm brooks dilator tip broke [separated] during reprocessing.The number of reprocessing cycles is unknown.
Event or Problem Description
According to the available information, this brooks dilator tip broke during reprocessing.The number of reprocessing cycles unknown.Coloplast territory manager indicates he was issued a set of brooks dilators when he started in 2015; however, the set was switched with another set at another hospital.He indicated "mentor" was on this handle versus "coloplast" on his set.
Additional Manufacturer Narrative
The research and development product support manager reviewed the returned brooks dilatator.During this review, it was noted that the end of the dilator is welded into place.The drawing for this device was made obsolete in 2015.The ¿mentor¿ name was changed to ¿coloplast¿ in 2007.It was suspected that this device is close to 20 years old, and it may have been reprocessed in an autoclave over the 75 times specified on our current dilator.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

• Brand Name: BROOKS DILATOR SET
• Common Device Name: CORPUS CAVERNOSUM DILATOR, REUSABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19865759
• Report Number: 2125050-2024-01161
• Device Sequence Number: 8102203
• Product Code: KOA
• UDI-Device Identifier: 05708932627320
• UDI-Public: 05708932627320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 91-9350
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown