MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29182400

Device Problems Crack (1135); Fracture (1260); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

According to the available information, loss of fluid - cracked tubing from pump to cylinder.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the shorter exhaust tube of the pump.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.Abrasion was noted on all pump tubes.All pump tubes were bent/curved.No functional abnormalities were noted either cylinder.Based on examination of the returned product, it was concluded that while in-vivo all pump tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the shorter exhaust tubing.The information received indicated the device had been implanted a little over 5 years.All pump tubing was bent/curved which indicated the tubing had been in this position for a period of time while in-vivo.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, nonconformance's and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8843076
• MDR Text Key: 152699053
• Report Number: 2125050-2019-00625
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539180
• UDI-Public: 05708932539180
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29182400
• Device Catalogue Number: ES2918
• Device Lot Number: 3851431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR