MAUDE Adverse Event Report: PROTEK MEDICAL PRODUCTS, INC. STERILE DISPOSABLE ENDOCAVITY NEEDLE GUIDE FOR ESAOTE EC123 PROBE; ENDOCAVITY (TRANS-RECTAL) BIOPSY NEEDLE GUIDE

Model Number	5145
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After being informed about the event, protek verified the existing inventory of the ref#(b)(4) and similar design needle guides.The inspection results show no loose cannula in any of the tested needle guides.Protek contacted the distributor and requested the used needle guide to be returned to us for evaluation, and asked for additional information to determine if the end user used the device per intended use (find out if the single-use device has been use more times, or have been re-sterilized, which would be outside of the labeling indications).Protek still waiting for responses.Note: this needle guide design has been on the market for over 10 years with no issues reported.Device not send back to us.
Event or Problem Description
An incident occured with device ref (b)(4), lot# 72335, exp 06.2021, on (b)(6) 2017.Incident concerns escaping of the metal cannula from its guide during the device use for prostate biopsy on a (b)(6) year old patient.Device was used and no further consequence have been notified, no patient injuries.

• Brand Name: STERILE DISPOSABLE ENDOCAVITY NEEDLE GUIDE FOR ESAOTE EC123 PROBE
• Common Device Name: ENDOCAVITY (TRANS-RECTAL) BIOPSY NEEDLE GUIDE
• Manufacturer (Section D): PROTEK MEDICAL PRODUCTS, INC.; 4125 westcor court; coralville IA 52241
• MDR Report Key: 6424035
• Report Number: 1934029-2017-00001
• Device Sequence Number: 10890732
• Product Code: ITX
• UDI-Device Identifier: 00841912101627
• UDI-Public: 00841912101627
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K971115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/06/2017

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: Physician
• Device Expiration Date: 06/28/2021
• Device Model Number: 5145
• Device Catalogue Number: 5145
• Device Lot Number: 72335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 80