MAUDE Adverse Event Report: GYRUS ACMI, INC PKS MOLLY FCP,3MM 33CM, 9-PIN (5/PK); ELECTROSURGICAL INSTRUMENTS

Model Number	910000PK
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device was plugged into a g400 generator.The generator correctly identified the forceps and set the default power settings to vp1/30w.At default settings, the device was activated on a saline-soaked paper towel.Both jaws energized, producing steam.The effect was replicated at 10 and 40 w.The reported malfunction could not be reproduced.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
The customer contacted olympus to report the device exhibited no output when tested prior to use (outside of the patient) in a gynecological laparoscopic procedure.The device was replaced with a non olympus reusable molly forcep.The intended procedure was completed.There was no patient harm or impact reported due to the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.The device evaluation and a review of the device history record (dhr) were conducted during this investigation.The device evaluation was provided in the initial report.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The reported malfunction could not be reproduced.No problem was detected with the device.Olympus will continue to monitor the field performance of this device.

• Brand Name: PKS MOLLY FCP,3MM 33CM, 9-PIN (5/PK)
• Common Device Name: ELECTROSURGICAL INSTRUMENTS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10978886
• Report Number: 3011050570-2020-00174
• Device Sequence Number: 4330111
• Product Code: GEI
• UDI-Device Identifier: 00821925034778
• UDI-Public: 00821925034778
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 910000PK
• Device Lot Number: FR855128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1