MalfunctionJCW
AMS 700 CX MS PUMP
Received Jul 15, 2026 · Event occurred Jun 22, 2026
Report 2124215-2026-38161 · MDR key 25834079
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1100951873
Product problems
- Deflation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL IMPLANTATION PROCEDURE FOR AN INFLATABLE PENILE PROSTHESIS (IPP), DURING TEST INFLATION, THE SURGEON WAS UNABLE TO DEFLATE THE DEVICE WITHOUT CONTINUOUSLY PRESSING THE RELEASE BUTTON. STANDARD TROUBLESHOOTING WAS PERFORMED, AND ALTHOUGH THE DEVICE COULD EVENTUALLY BE DEFLATED, THE SURGEON ELECTED NOT TO USE THE IMPLANT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.