MAUDE Adverse Event Report: GYRUS ACMI, INC. PK CUTTING FORCEPS, 5MM, 33CM; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE

Model Number PK-CF0533

Device Problems Energy Output Problem (1431); Output Problem (3005)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

Olympus received an (ahs mdip # 25274) report from alberta health service through via email that the device "pk cutting forceps, 5mm, 33cm" malfunctioned.Not cauterizing while activated.No harm was reported.No patient injury, no user injury reported due to the event.

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.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 device return evaluation.The subject device was received for evaluation.The model number is a pk-cf0533 with lot number unknown visual inspection noted the lot number cannot be verified as the device was not returned in its original packaging.There is no lot number on the physical device as well.The jaws were received opened with the latch in the ¿on¿ mode.Visual inspection found that there is some foreign material on the jaws, shaft and handle which is consistent with use.The jaw symmetry is not balanced as the jaws are misaligned.The first point of contact for the jaws is at the distal end; this is consistent with standard.The jaw aperture measurement was taken inside the first teeth of the jaw, measured at.310¿ ", (standard is.300¿ +/-.100¿).The jaw mesh is not good.The insulation of the jaw legs was inspected and found there were no tears or cuts in the insulation.The flare is in intact and has no damage or cracks.The blade extends/retracts and cut the dental dam as designed.The lock function engages/releases as designed, and the shaft is normal with no indications of bends or dents.The device was plugged into the test esg-400 generator; the generator displayed pk coag at power level 100 effect 3 and a functional test was performed.Functional test showed the cutting forceps was able to deliver energy with no issues.Based on evaluation findings, the testing of the device was not able to confirm the reported issue of not cauterizing while activated as no issues observed during the functional testing.Additionally, since it is unable to confirm user complaint, a follow up regarding concomitant devices used on the device was performed.However, the customer did not have the information.Follow up noted "the customer stated they don't have any information".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 (updated h6/h10), to update h4, and to correct g2 (health professional was inadvertently omitted from the initial).Manufacturing date was listed as july 2022 but an exact date was not provided.Therefore, the date in h4 will default to the first of the month.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.Although the complaint "not cauterizing while activated" was not confirmed, the reported failure is a known phenomenon likely resulting from having the distal jaw tips come in contact with each other when attempting to coagulate.The event can be prevented by following the instructions for use (ifu) which state: "if forceps jaws come in contact with each other when the power is activated, instrument will short out and the generator display will show ¿re-grasp¿.Release the forceps jaws so they are not in contact with each other and the device will become operational." "both forceps jaws should be in equal contact with tissue for optimum coagulation.If the device's coagulation feature is activated on a thin or uneven layer of tissue being grasped, the forceps may pierce the tissue and/or come in contact with each other.This would cause the re-grasp error to come up on the generator.This would then indicate that the distal jaws would need to be re-positioned to grasp the optimal section of tissue." olympus will continue to monitor field performance for this device.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Type of Device: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 16058311
• MDR Text Key: 306520896
• Report Number: 3005975494-2022-00072
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2023

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: PK-CF0533
• Device Lot Number: FR234895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 02/16/2023; 03/15/2023
• Supplement Dates FDA Received: 03/14/2023; 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1