MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, two subject devices broken.The user facility was reprocessing the subject device as follows, hand wash.Air blow dry.Dryer used for 10 mins on 55 degrees.Neutral chemical.Vpro- max 35min cycle.The user facility did not provide other detailed information.There was no report of patient injury associated with the event.This mdr is the two of two reports.

Manufacturer Narrative

This supplemental report is being submitted to additional information.Olympus medical systems corp.(omsc) confirmed the following from information from olympus australia (oaz).At the adhesive part between the resin tightening ring and the stainless steel part inside, the event occurred due to the interface peeling of the adhesive on the tightening ring.Corrosion occurred at the interface between the adhesive and stainless steel parts.Corrosion can be presumed to be crevice corrosion.Crevice corrosion occurs when water enters the interface between stainless steel and resin for a long time.The subject device was returned to omsc for evaluation.In the evaluation of omsc the following was confirmed; a total of 18 maj-891s were returned.It was confirmed that the locking ring was detached in 2 out of 18 devices.The adhesive on the device has interfacial peeling and has turned brown.We checked the application state of adhesive on the actual device with the locking ring detached, but it was applied to all circumferences.Therefore, it is presumed that there was no problem in the adhesive application work at manufacturing.The remaining 16 devices did not come off even if the locking ring was pulled by hand.Although there was a difference in degree, the adhesive that slightly protruded from the main body and the locking ring turned brown.It was also confirmed that the gap between the main body and the metal part turned brown in some devices.In each case, no obvious stain residue could be confirmed.The exact cause of the reported event could not be conclusively determined.However there was the possibility that the reported phenomenon was attributed to the adhesive deteriorated and peeled off due to the combination of chemical stress during reprocessing and mechanical stress which caused by the following factors.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11010189
• MDR Text Key: 221558657
• Report Number: 8010047-2020-10375
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAJ-891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1