MAUDE Adverse Event Report: GYRUS ACMI INC CYBERWAND PROBE SET,3/BOX; CYBERWAND DUAL ACTION ULTRASONIC

Model Number CW-RBPBX

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The primary packaging containing the cw-rbpbx has not been returned to the service center for evaluation for foreign material inside the package.Therefore, the exact cause of the reported event cannot be determined at this time.The original equipment manufacturer (oem) performed a device history record review for this product, and all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of (b)(4) units were manufactured under this lot number, and there were no non-conformances, reported scrap, or reported process deviations related to the reported failure.(b)(4).Photographs of the primary packaging of the device containing the reported foreign material were received, an evaluation of the photos has not been initiated.Upon completion of the evaluation a supplemental report will be submitted.

Event Description

The service center received a report of one package of cyberwand probe set (model cw-rbpbx), lot number w1901098, that had foreign material inside the primary packaging.It was reported that the charge nurse was performing incoming inspection of product, when it was observed that the primary packaging for the cw-rbpbx contained lint/foreign material, breaching the sterility of the product.It was reported that the package was stored on a shelf and was not torn, dented, or breached to the outside environment.The package was removed immediately from service and did not come into contact with any patient.The remaining inventory was inspected and no further packages were found to contain foreign material.Photographs of the received condition device have been received at the service center for evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation.The customer returned a cw-rbpbx cyberwand probe and it was evaluated for the report of "it was discovered there was lint found in the sterile packaging for the cw-rbpbx." the device was returned in the original sealed tyvek pouch.Upon inspection of the received device the complaint was confirmed as lint is present inside the sealed pouch.A definitive root cause for the reported problem could not be determined.This product is no longer manufactured by cybersonics inc.For this reason, no additional corrective action will be taken at this time.Olympus will continue to monitor the field performance of this product through trending.

• Brand Name: CYBERWAND PROBE SET,3/BOX
• Type of Device: CYBERWAND DUAL ACTION ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 9774306
• MDR Text Key: 199884601
• Report Number: 2951238-2020-00351
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

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
• Device Operator: No Information
• Device Expiration Date: 06/03/2024
• Device Model Number: CW-RBPBX
• Device Lot Number: W1901098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1