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

Model Number PK-CF0533

Device Problems No Device Output (1435); Output Problem (3005)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.This report will be supplemented accordingly following investigations.

Event Description

It was reported that there was no energy/coagulation occurring when the device seal button was activated.The issue occurred during a therapeutic tlh (total laparoscopic hysterectomy) procedure.The intended procedure was completed with a new pk-cf handpiece.There was no patient impact or harm reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device evaluation and the legal manufacturer's investigation.The dhr (device history record) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.No associated (non conformances) ncrs, reported scrap or recorded process deviations relating to the reported failure.The device was returned in its' original package, which was open prior to receipt.The device was received with the jaws opened, lock off.A visual inspection indicates that there is some foreign material on the jaws, cable, and handle.The jaw symmetry is aligned.The first point of contact for the jaws is at the distal end; this is consistent with the standard.The jaw aperture measurement was taken inside the first teeth of the jaw, and measured at.306", (standard is.300¿ +/-.100¿).The jaw mesh is normal, no abnormalities noted.The insulation of the jaw legs was inspected and found no abnormalities.The flare is cracked/split, but still intact to the complaint device, no missing pieces.The lock function works and the slider that is used to toggle the device from lock to unlock is normal.The trigger lever was manipulated, and engaged over 50 times without any anomalies, or malfunctions.The shaft itself is normal, and the rotation of the shaft is also normal.The blade extends/retracts and cuts the dental dam as designed.There is a slight push to the dental dam when fully extending the blade during cutting.The blade itself does not appear to be dull.The lever for the blade has no restriction.Functional testing was performed with a test generator.The generator recognized the device and displayed no errors on the screen.Functional testing observed consistency of coagulations while the saline soaked gauze was fully grasped by the forceps at the distal end side and activated with the blue switch on the pk device.There were no abnormalities during the functional test.The reported issue is a known phenomenon resulting from possible error in setting up the device or pre-testing the device prior to procedure.On page 2 of the device ifu (instruction for use), it states: ensure the olympus electrosurgical generator esg-400 displays pk_cf_5mm indicating that the pk cutting forceps is selected.Also: pre-test the device to verify complete electrical activity and generator setting.Olympus will continue to monitor the field performance of this device.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Type of Device: PK CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12128984
• MDR Text Key: 260302691
• Report Number: 3011050570-2021-00081
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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: PK-CF0533
• Device Lot Number: FR947197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1