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

Model Number E8213

Device Problem Mechanical Problem (1384)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Customer reported the" grasper is not working, handle is not working".The reported issue found during an unknown event.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the forceps jaw was broken.The unit was noted to be beyond economic repair.The reported issue was confirmed.Follow up is in progress to gather additional information regarding the reported event.To date, no response is received from the customer.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: based on the lot number the manufacturing date of the device was in the month of june 2003 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 19 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the damage occurred due to user mishandling and excessive force that was applied to the device.The root cause of this event was unable to be identified.The following is included in the instructions for use: ¿excessive squeezing force on handles can lead to failure of forceps jaws." (page 6); and "prior to each use, inspect jaws/scissors blades and distal joints for any burrs, cracks, or rough edges.Do not use if any irregularities are present.Open and close handles to ensure smooth action." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.

• Brand Name: USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS
• Type of Device: RIGID ENDOSCOPIC BIOPSY FORCEPS, REUSABLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16543982
• MDR Text Key: 311427999
• Report Number: 3005975494-2023-00045
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 00821925001237
• UDI-Public: 00821925001237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-GEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

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: GG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 05/01/2023
• Supplement Dates FDA Received: 04/27/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1