MAUDE Adverse Event Report: GYRUS ACMI, INC. POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION

Model Number PS-0537CJDA

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2023

Event Type  Injury  

Event Description

The customer reported to olympus that during ligation and cauterization on the fallopian tubes, this powerseal got stuck to the tissue.The user was able to remove the device but ended up tearing the patient's tissue in the process.The intended procedure was completed using a similar device and a follow-up procedure was not needed for the tissue tear.Additional information obtained that it was a minor tear and a secondary hemostasis, bovie, was used to cauterize and resolve the issue.The device was inspected before use and was normal.There were no reports of further patient or user harm associated with this event.

Manufacturer Narrative

Appropriate term: minor tear.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for evaluation, the customer¿s complaint could not be confirmed.Therefore, the root cause could not be determined.This supplemental report includes a correction to e2 and e3 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the physical device evaluation.The device was returned to olympus for inspection, and there were no reportable malfunctions/defects observed.Therefore, the root cause of the reported event could not be determined.This supplemental report includes a correction to d9 and h3 from the previous submissions.Also, an update has been made to the h6 codes accordingly.Olympus will continue to monitor field performance for this device.

• Brand Name: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• Type of Device: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• 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: 17083724
• MDR Text Key: 316789162
• Report Number: 3011050570-2023-00058
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925044555
• UDI-Public: 00821925044555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS-0537CJDA
• Device Lot Number: FR301030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female