MAUDE Adverse Event Report: GYRUS ACMI, INC PLASMA J-HOOK W/CORD 33CM

Model Number 956010PC

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the evaluation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the box of 956010pc was found with a stain on the package.There were no further details regarding the reported event.No patient involvement on this report.No user harm or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Device evaluation of the returned device, the complaint was confirmed.Water stains were present on the outer shipping container as well as the inner shelf box.No staining or damage was noted on any of the 5 sealed device trays.The water damage is believed to be an isolated incident which occurred during transportation.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report # 2 is being submitted to provide the correction to g3.Aware date (b)(4) 2030 is being corrected to (b)(4) 2020 filed under sr #1 ((b)(4)).

• Brand Name: PLASMA J-HOOK W/CORD 33CM
• Type of Device: PLASMA J-HOOK W/CORD 33CM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10527889
• MDR Text Key: 206777187
• Report Number: 3011050570-2020-00075
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K050460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 956010PC
• Device Lot Number: FR928606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1