MAUDE Adverse Event Report: BTG YOKNEAM Iceseed 90 Degree Needle; Unit, Cryosurgical, Accessories

Model Number	FPRPR3202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	11/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event- publish date selected detailed product information was not provided to bsc.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.Harris, j., will, r., robinson, e., & finley, d.S.(2025).Rectal spacer gel displacement of the rectum during prostate cryoablation: a case series.Journal of urologic oncology, 23(3), 247-252.Https://doi.Org/10.22465/juo.255000900045.
Event or Problem Description
It was reported that cellulitis occurred, requiring intervention.The purpose of this article was to describe a novel case series using rectal spacer gel to displace and protect the rectum during prostate cancer cryoablation.Fifty men with clinically localized grade group 1-5 prostate cancer underwent concurrent rectal spacer gel and primary (n=27) or salvage (n=23) prostate cryoablation using the spaceoar hydrogel and icepearl (2.1 mm/14 gauge) and/or iceseed (1.5 mm/17 gauge) cryoablation needle(s).Of the 50 cases, there was only one case with a complication of perineal cellulitis, as a clavien-dindo grade ii complication.The cellulitis was able to be resolved with an incision and drainage of the fluid collection and antibiotics.There were no further complications observed.

• Brand Name: Iceseed 90 Degree Needle
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG YOKNEAM; tavor building 1; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): Galil Medical Ltd.; tavor bldg. 1; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25896683
• Report Number: 2124215-2026-39351
• Device Sequence Number: 10141216
• Product Code: GEH
• UDI-Device Identifier: 07290104830235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FPRPR3202
• Device Catalogue Number: FPRPR3202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown