MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3560
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician used a cryoablation needle with a slight bend at the needle shaft.The needle tested fine with no visible leak detected, and the bent needle was barely noticable during treatment.The physician proceeded to use the needle.Needle placement was unaffected and the needle did not bend further upon usage.The case was completed with no impact to the patient.The labelling of the product states that bent needles should not be used for cryoablation procedures.
Event or Problem Description
It was reported that the physician used a cryoablation needle with a slight bend at the needle shaft.The needle tested fine with no visible leak detected, and the bent needle was barely noticable during treatment.The physician proceeded to use the needle.Needle placement was unaffected and the needle did not bend further upon usage.The case was completed with no impact to the patient.The labelling of the product states that bent needles should not be used for cryoablation procedures.
Additional Manufacturer Narrative
The needle was returned to the manufacturer for investigation.A slight bend was observed on the needle shaft.From the reported information, there is no indication that the bend was introduced during handling or use by the treating physician.Manufacturing review did not find any evidence of any process related issue or deviation that may have caused the bend on the needle shaft.The most probable root cause of this complaint is likely related to the transportation or storage of the needle between the manufacturing site and the user.

• Brand Name: ICESPHERE 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10338926
• Report Number: 2134265-2020-10100
• Device Sequence Number: 11627515
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: FPRPR3560
• Device Catalogue Number: FPRPR3560
• Device Lot Number: T0402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1