MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL RESIST 16CM; INFLATABLE PENILE PROSTHESIS

Model Number QS89161000

Device Problems Crack (1135); Leak/Splash (1354); Pumping Problem (3016)

Patient Problem No Information (3190)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, pump leaked and tubing was cracked.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

Event Description

Additional information to clarify the reported event - the pump failed.Leak and cracked tubing were reported.The device was removed.

Manufacturer Narrative

The follow-up was created to document the conclusion of the investigation.A titan pump and two cylinders were received for evaluation.Examination and testing of the components revealed a separation in the exhaust tubing of cylinder 2, near the strain relief.Testing revealed this to be a site of leakage.Microscopic examination revealed the surfaces to be rough and irregular, indicating stress was exerted.Partial separations within abrasion were noted on the exhaust tubing of cylinder 2, the longer exhaust tube of the pump and inlet tube of the pump.Testing revealed these to not be sites of leakage.No functional abnormalities were noted with the pump or cylinder 1.Based on recreation of the position of the pump tubes according to the abrasion pattern, this demonstrates that the longer exhaust tubing and inlet tubing were overlapping each other.This positioning, in combination with device usage over time, could contribute to sufficient stress on the exhaust tube of cylinder 2 to result in a separation through the exhaust tubing near the strain relief of cylinder 2.A separation of this type would then allow the loss of fluid, making the device inoperable.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 revealed no trends for this lot.Review of nonconforming reports revealed no non-conformances for this lot.No capas are associated with this lot.

• Brand Name: TITAN SCROTAL RESIST 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9405115
• MDR Text Key: 169000888
• Report Number: 2125050-2019-01107
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS89161000
• Device Catalogue Number: QS8916
• Device Lot Number: 0919349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 09/03/2019; 09/03/2019
• Supplement Dates FDA Received: 02/03/2020; 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR