MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE; PENILE PROSTHESIS

Model Number 5192602022

Device Problems Fracture (1260); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

According to available information, this device required replacement due to lack of rigidity.It was noted the lack of rigidity was at the base of the device made it impossible to get a proper erection.The doctor believes the device broke.No other adverse patient effects were reported.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Manufacturer Narrative

Genesis malleable rods 1 and 2 were received for evaluation.Rod 1 was received fully separated.The detachment ends of the separated pieces of the rod showed surfaces to be rough and irregular, indicating stress was exerted.The inner core for rod 1 was separated.Examination by the senior manager of product development revealed that there was limited blood on the inside of the malleable rod which may indicate a full separation may have occurred after explant.Microscopic examination of the silver strands on the inner coil revealed the silver strands appeared to be melted or in contact with excess heat.Examination of the silver strands appeared some to be smooth and rounded indicating contact with heat, while others were rough indicating fracture due to fatigue.The temperature to melt silver is 1763 degrees f.As the autoclave cycle is 250 degrees f, the melted appearance may have occurred due to contact with cauterizing instrumentation.The strands on the inner coil had fractured at different lengths.Rod 2 was received intact.When tested, the inner core did not hold the required angle retention.Based on examination and testing, and further examination by the senior manager of product development, it was confirmed that the inner core of the malleable rod 1 most likely fractured.As a result of the inner core fracture, the outer rod material may have started to fracture.In addition, the inner core of malleable rod 2 was also fractured in a similar location to rod 1, but the rod was still intact.However, based on the information received and examination of the returned product, it is unclear when the full separation of the malleable rod 1 may have occurred.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15148165
• MDR Text Key: 297071143
• Report Number: 2125050-2022-00747
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 5192602022
• Device Catalogue Number: 519260
• Device Lot Number: 6336745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR