MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number ESR8202400

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 02/21/2018

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.Should additional facts prompt us to alter or supplement any information of 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, potential leak in tubing from reservoir to cylinder/pump.

Manufacturer Narrative

A titan otr pump, two cylinders and a reservoir were received for evaluation.A separation was noted at the inlet tube/strain relief junction of the reservoir.Testing revealed this to be a site of leakage.The separation surfaces appear to be rough and irregular.Surface abrasion was noted on all tubing of the pump, cylinders and reservoir.No functional abnormalities were noted with the pump or the cylinders.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.Based on quality's examination, quality concluded the abrasion noted on pump tubing indicated they had twisted and resulted in enough stress to cause a separation in the reservoir inlet tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: (2BO)TITAN OTR INFRA ZERO ANG
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7356905
• MDR Text Key: 103014215
• Report Number: 2125050-2018-00234
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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: ESR8202400
• Device Catalogue Number: ESR8202400
• Device Lot Number: 3330526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR