MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER HANDPIECE, ANGLED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number MDHP100A

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the reported issue was confirmed.During a visual inspection of the device; it was observed that there were minor kinks on the cable insulation of the hand piece.There were no signs of physical damage on the connectors.During further testing, the device failed the resistance tests.The most possible cause for the hand piece failing the break out box test could be attributed to the kinks in the cable.A device history record (dhr) did not find any defects or nonconformities.All records indicate that the device was manufactured in accordance with all applicable procedures.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

The user facility reported that the handpiece does not rotate, it was not functioning as intended.No patient involvement was reported.No additional information has been obtained.

• Brand Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 10405543
• MDR Text Key: 203154853
• Report Number: 1037007-2020-00032
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

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: Health Professional
• Device Model Number: MDHP100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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