MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR SCROTAL 20CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9201400

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

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

According to the available information, the inflatable penile prosthesis was explanted due to a malfunction, cracked tubing at the pump.The device was replaced with another inflatable penile prosthesis.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump and two cylinders were received for evaluation.Microscopic examination revealed rough and irregular surfaces noted on the detachment site of the short pump exhaust strain relief and the detachment site of the cylinder 2 exhaust tube indicating sufficient stress was exerted to separate the site.Microscopic examination revealed a group of partial separations within abrasion on the longer pump exhaust tubing, and the pump inlet tubing.These groups were not sites of leakage.Microscopic examination revealed a group of partial separations on the strain relief of the short pump exhaust tubing, indicating contact with unshod instrumentation.This was not a site of leakage.Surface abrasion was noted on the longer pump exhaust tubing and pump inlet tubing, indicating repetitive contact between surfaces.No functional abnormalities were noted with the pump or either cylinder.Based on examination of the returned product, it was concluded that the longer pump exhaust tubing and the pump inlet tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation in the shorter pump exhaust tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.

• Brand Name: TITAN OTR SCROTAL 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9459984
• MDR Text Key: 178741307
• Report Number: 2125050-2019-01127
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR9201400
• Device Catalogue Number: QSR920
• Device Lot Number: 3171277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR