MAUDE Adverse Event Report: GYRUS ACMI, INC USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS

Model Number E8213

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation confirmed the reported issue.The device was inspected and found the device jaws were bent and damaged causing the unit to not function properly.In addition, missing red dot from release button was observed.Based on device evaluation findings the reported issue was confirmed.Probable cause of the issue can be due to handling and or maintenance issue.

Event Description

It was reported that the device cups were found broken.The jaws were found bent, dented and will not cut.There were no further details provided regarding the event.No patient involvement reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: d4, g4, g7, h2, h4, h6 and h10.The device was manufactured sometime in may 2013.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the physical damage observed on the device was most likely due to user mishandling.The instructions for use state, "excessive squeezing force on handles can lead to failure of forceps jaws.Check proper alignment of jaws/blades and telescope.Both should be visible when viewing through the telescope.Jaws/blades should be visible whether they are in the open or closed position.".

• Brand Name: USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS
• Type of Device: USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11116682
• MDR Text Key: 227080590
• Report Number: 1519132-2021-00001
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-GEN
• 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: 02/18/2021

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: Health Professional
• Device Model Number: E8213
• Device Lot Number: BT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1