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

Model Number 5177701400

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, genesis pump leak/fracture.The pump was revised/replaced.Device returning.Additional info.Per tm on 11/17/2020: "fracture is in the bulb of the pump." the lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

A titan pump was received for evaluation.Examination and testing of the returned components a separation in the pump bulb between ribs 3 and 4 from the pump body.Testing revealed this to be a site of leakage.Microscopic evaluation revealed partial separations near the site of separation, indicating contact with instrumentation.These were not sites of leakage microscopic evaluation revealed surface abrasion on the pump inlet tubing and shorter pump exhaust tubing.No functional abnormalities were noted with the shorter or longer connector/exhaust tubing segments.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the pump bulb occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.As no other abnormalities were noted, the reported complaint cannot be confirmed.A review of the device history record confirmed that the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.

• Brand Name: GENESIS MALLEABLE
• Type of Device: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11009248
• MDR Text Key: 221776181
• Report Number: 2125050-2020-01270
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932319621
• UDI-Public: 05708932319621
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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
• Device Operator: Health Professional
• Device Model Number: 5177701400
• Device Catalogue Number: 517770
• Device Lot Number: 6778965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/07/2021
• Patient Sequence Number: 1