MAUDE Adverse Event Report: GYRUS ACMI, INC CUT/FCP,5MM/33C DESIGN III (5/PK)

Model Number 3005PK

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during initial inspection the distal end tip of the unit was found bent and it pierced the sterile packaging.The device could not be used as the sterility was compromised.There was no patient involvement or user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number, device evaluation and investigation conclusion and customer response, update.Device evaluation did not confirm the reported complaint of tip bent to the point that it pierced the sterile packaging.However, the damage on the packaging would cause the forceps unusable because it is no longer sterile.This damage could have happened during shipping or mishandling.Device history record was reviewed and showed the product met all specifications upon release.Per the ifu (instruction for use): the product is sterile unless the package is opened or damaged.The device is designed for one-time use.Do not reuse or re-sterilize.Check the integrity of the packaging.Do not use the device if the packaging is open or damaged.Sterility may be compromised.Olympus will continue to monitor the field performance of this device.Further communication with the customer conveyed the following information.The customer does not have any pictures that can be provided.There was no patient injury or infection.This issue was noted upon arrival.The device is stored on shelved.The customer advised that they did not recall seeing any damage.No further information provided.

• Brand Name: CUT/FCP,5MM/33C DESIGN III (5/PK)
• Type of Device: CUT/FCP,5MM/33C DESIGN III (5/PK)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11083463
• MDR Text Key: 228074696
• Report Number: 3011050570-2020-00195
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K023492
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3005PK
• Device Lot Number: FR964632
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1