AMS 700 SPHERICAL RESERVOIR
Received Jul 7, 2026 · Event occurred May 25, 2026
Report 2124215-2026-36459 · MDR key 25740461
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404161Catalog number
72404161
Lot number
859955008
Product problems
- Mechanical Problem
- Material Puncture/Hole
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT A CRACK WAS FOUND IN THE RESERVOIR CONNECTING TUBE, SO THE RESERVOIR WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404014. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100538343. MODEL/CATALOG DESCRIPTION: CXR 18CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72401110. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 802129004. MODEL/CATALOG DESCRIPTION: PUMP CXM. UNIQUE IDENTIFIER (UDI) #: THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.