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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-APP
Device Problems Failure to Cycle (1142); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2020
Event Type  Injury  
Event Description
It was reported that patient underwent a replacement procedure of his ambicor penile prosthesis (app).Patient states he is dissatisfied with device because it did not cycle properly.All components were explanted and a new inflatable penile prosthesis (ipp) was implanted.
 
Event Description
It was reported that patient underwent a replacement procedure of his ambicor penile prosthesis (app).Patient states he is dissatisfied with device because it did not cycle properly.All components were explanted and a new inflatable penile prosthesis (ipp) was implanted.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation of failure to cycle was not confirmed via product analysis.The ambicor cylinders, pump and tubing were visually inspected.Both cylinders had multiple leaks in the rear tip cylinder body that was result of sharp instrument damage; holes were present.Cylinder 2 had broken fabric treads in cylinder body.There was no damage to the pump.The krt identified to be cut separated with sharp instrument damage.Based on the results of this investigation, no escalation is required.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10339022
MDR Text Key200819951
Report Number2183959-2020-03238
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNK-P-APP
Device Catalogue NumberUNK-P-APP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Date Manufacturer Received08/14/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
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