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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE Back to Search Results
Model Number 720054-02
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2020
Event Type  Injury  
Event Description
It was reported that the patient went to the hospital two weeks before surgery, saying the spectra penile prosthesis length was not correct.As a result of the inspection, it was confirmed that the length was not correct.The patient had the spectra penile prosthesis replaced and extended the tip by 1.5 cm.Following the surgery, the patient was stable and improved.The event resolved.
 
Manufacturer Narrative
H3 device evaluation the rear tip extender was not returned for analysis.The spectra cylinders were visually and functionally tested.Both cylinders had sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments in cylinder body.This damage is consistent with explant damage.Both cylinders passed the bend test with a force readout of less than 1390 grams.The cylinders therefore performed within specification.Product analysis was unable to confirm the reported event.
 
Event Description
It was reported that the patient went to the hospital two weeks before surgery, saying the spectra penile prosthesis length was not correct.As a result of the inspection, it was confirmed that the length was not correct.The patient had the spectra penile prosthesis replaced and extended the tip by 1.5 cm.Following the surgery, the patient was stable and improved.The event resolved.
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Type of Device
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11210426
MDR Text Key228157755
Report Number2183959-2020-06400
Device Sequence Number1
Product Code FAE
UDI-Device Identifier00878953005218
UDI-Public00878953005218
Combination Product (y/n)N
PMA/PMN Number
K090663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 02/25/2021
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? Yes
Device Operator Lay User/Patient
Device Expiration Date08/28/2023
Device Model Number720054-02
Device Catalogue Number720054-02
Device Lot Number1000155810
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Initial Date Manufacturer Received 12/29/2020
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received02/03/2021
Supplement Dates FDA Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
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