REZUM
Report
- Report Number
- 2124215-2025-83196
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- October 27, 2025
- Report Date
- January 9, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729992547
- PMA / PMN Number
- K191505
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G1. MANUFACTURING SITE: CORRECTION. G4 PREMARKET/510K: K190093, K191505. UPON RECEIPT, THIS PRODUCT WAS THOROUGHLY ANALYZED IN OUR QUALITY ASSURANCE LABORATORY. ANALYSIS OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORTED CLINICAL OBSERVATION. THE REZUM KIT WAS RETURNED IN AN UNOPENED SEALED PACKAGE. THE SYRINGE BARREL COMPONENT WAS VISUALLY INSPECTED AND SENT TO THE ARDEN HILLS ANALYTICAL LAB (AHAL) TO ANALYZE THE ALLEGED MOISTURE THAT WAS VISIBLE INSIDE THE SYRINGE BARREL OF THE RETURNED SAMPLE. THE SYRINGE BARREL COMPONENT OF THE RETURNED DEVICE WAS ANALYZED USING ATTENUATED TOTAL REFLECTANCE INFRARED SPECTROSCOPY (ATR-IR). THIS ANALYSIS FOUND THE ALLEGED SUBSTANCE IN THE SYRINGE BARREL TO BE CONSISTENT WITH FLUOROSILICONE LUBRICANT. NUSIL MED 400 IS A FLUOROSILOCONE LUBRICANT AND IS PART OF THE BILL OF MATERIALS (BOM). THIS MATERIAL HAS BEEN CHARACTERIZED AND DETERMINED TO BE BIOCOMPATIBLE, AND IS USED IN THE ASSEMBLY OF THE SYRINGE COMPONENT OF THE DEVICE. PER BOSTON SCIENTIFIC WORK INSTRUCTION 92271201, SILICONE LUBRICANT IN THE SYRINGE BARREL IS ACCEPTABLE. THE REVIEW COMPLETED ON THE DEVICE HISTORY REVIEW (DHR) FOR THIS DEVICE CONFIRMED THAT IT MET SPECIFICATION PRIOR TO RELEASE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE REPORTED FOREIGN MATERIAL PRESENT IN DEVICE EVENT. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, BOSTON SCIENTIFIC CONCLUDES THAT NO FOREIGN MATERIAL WAS PRESENT IN THE DEVICE AND THEREFORE, A CONCLUSION CODE OF DEVICE PROBLEM EXCLUDED WAS ASSIGNED TO THIS INVESTIGATION.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. G4 PREMARKET/510K: K190093, K191505.
IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 2 OF 5
IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 2 OF 5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767775 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M006D2201-003 | 0037457222 | 08714729992547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |