MAUDE Adverse Event Report: GYRUS ACMI, INC PK CUTTING FORCEPS, 5MM, 33CM

Model Number PK-CF0533

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly following investigations.

Event Description

When device pk-cf0533 forceps were removed from packaging debris present found.The debris could be seen through the plastic packaging.The issue found prior to a tubal ligation procedure.The device was replaced and the intended procedure was completed.No harm, impact to the patient was reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Return device was evaluated.Visual inspection as received condition found no abnormality on the appearance.The tray was completely sealed and has no physical damage.Without opening the top lid, and inspected the device as is under a magnify lamp found no debris anywhere inside the packaging.The top lid was then removed to inspect the content inside but still no debris was found.The tray has good adhesive around the edges, and the device is clean.Therefore, the reported complaint was not confirmed.Olympus will continue to monitor the field performance of this device.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Type of Device: PK CUTTING FORCEPS, 5MM, 33CM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11592135
• MDR Text Key: 243676598
• Report Number: 3011050570-2021-00059
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (y/n): N
• PMA/PMN Number: K142759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK-CF0533
• Device Catalogue Number: PK-CF0533
• Device Lot Number: FR996885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1