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

Model Number MAJ-891

Device Problems Material Discolored (1170); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The subject device was received and evaluated.Device evaluation found the device cock part was observed to be discolored (brown).The adhesive part was observed altered due to the sterilization performed was not applicable to the device.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported that when two maj-891's (forceps/irrigation plug) were autoclaved, the shaft of the cock male (irrigation plug) turned brown (originally white).According to the reporter, both of the device were purchased within a year and since the correct sterility methods were not explained at the time of the delivery, device were sterilized with stellato (stellat sterility manufactured by canon inc.).There was no patient harm or injury reported due to the event.No user injury reported.According to the reporter, "the correct sterilization method was explained on (b)(6) 2022, and the color changed when autoclave sterilization was performed".Two complaints were opened to address the two (2) maj-891 with complaint of the cock part was discolored (turned brown) , sterilization that is not applicable was performed.Patient identifier (b)(6) for maj-891.Patient identifier (b)(6) for maj-891.This report is 1 of 2 related to a report with patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.After analysis, the same ingredient as the glue used during manufacturing was detected.Therefore, it was determined that the adhered material did not come from the outside, but the material was an alteration of the glue applied to the cock.The user facility performed sterilization by sterrad.The cause of alteration of the glue of the cock was likely incompatible sterilization, or damage caused by autoclaving performed under conditions or procedures other than those described in the instructions for use.The following is included in the instructions for use (ifu) and may have helped prevent the event."compatible reprocessing methods" "compatibility summary¿ where sterilization method is described.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14342862
• MDR Text Key: 299869416
• Report Number: 8010047-2022-07926
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1