MAUDE Adverse Event Report: GYRUS ACMI, INC MODEL 970010PC, 5 PACK, 33CM, OMNI PKS; PKS OMNI

Model Number	970010PC
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device evaluation can be performed since the device is not returning.The subject device was discarded by the user facility.The dhrs (device history records) 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.Dhr review for this lot found no associated ncrs (nonconformance's), reported scrap or recorded process deviations relating to the reported failure.The observed failure is a known phenomenon likely resulting from inadvertent movement of the device distal tip potentially out of sight causing potential stress to be placed on the distal end.Ifu (instruction for use) : on page 4 of the device ifu (p9100501-001_af), it states: "keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury.If visualization of the treatment site or device is lost during the procedure, stop activation immediately.Do not proceed until visibility is restored." olympus will continue to monitor complaints for this device.
Event or Problem Description
As reported, the tip of the instrument came off in the middle of the procedure.It was removed from the patient without any injury.The instrument was only used for about 10 minutes.The intended procedure was a therapeutic tlh ( total laparoscopic hysterectomy ).The procedure was completed using another instrument.There was no patient harm or injury reported due to the event.No user injury reported.

• Brand Name: MODEL 970010PC, 5 PACK, 33CM, OMNI PKS
• Common Device Name: PKS OMNI
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14587590
• Report Number: 3011050570-2022-00070
• Device Sequence Number: 2097473
• Product Code: GEI
• UDI-Device Identifier: 00821925038097
• UDI-Public: 00821925038097
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: 970010PC
• Device Lot Number: KR151239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown