MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BRIDGE, ONE WAY

Model Number 162W -0085

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A boroscope was used to inspect the channel of the device and found an unknown brown stain / foreign material inside the channel.The brown substance is not the glue or a part of the device component.The root cause of the reported event could not be determined.As part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to assess and observe the user facilities reprocessing practice and to provide reprocessing training if necessary.To date, the ess visit has not yet been finalized.

Event Description

Olympus was informed that during an ureteroscopy procedure, an unknown brown substance came out of the device and fell inside the patient's urethra.The unknown brown substance was retrieved.The procedure was completed using a different but similar device.No patient injury occurred.

Manufacturer Narrative

The ess visited the user facility on (b)(6) 2016 to assess and observe the user facilities reprocessing practice and to provide a reprocessing training.No reprocessing deviations were noted during the in-service.

Manufacturer Narrative

This supplemental report is being submitted to correct the lot number of the device and provide additional information received from the oem.The oem performed a technical analysis and determined that the risk of using a20976a/a20977a bridges considering the phenomenon of adhesive falling off from the bridge is assessed as low.Before each use or sterilization cycle, the devices should be checked for glue peeling off inside the working channel.Any loose glue particles have to be removed.In (b)(6) 2016, the oem initiated an on going investigation to determine the root cause for this issue and upon completion appropriate countermeasures will be defined.

Manufacturer Narrative

Based on the investigations performed by the original equipment manufacturer (oem) on the returned device, the brown substance, which customer reported to fall out of the bridge was identified as adhesive.This adhesive is applied internally during manufacturing to seal the joint between the telescope channel and the working channel to facilitate smooth insertion of accessories.The adhesive turns brown during the curing process.In addition, there was a superficial damage on the bridge, such as scratches, dents and cuts.There were some residue of reprocessing fluids and light corrosion.These additional findings were attributed to improper handling of the device.The particles of the adhesive which may fall out of the bridge are small and thus will be flushed out of the patient naturally or removed during procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide the correct aware date of report, which december 16, 2016 and not december 16, 2017.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).The oem conducted a review of the device history records (dhr) for the concerned lot number and revealed there were no deviations or non-conformities for this device.However, further investigations noted the glue was found to be of insufficient stability due to a change in the manufacturing process at the end of 2013.In an effort to prevent a potential risk to the patient health, a field safety corrective action (fsca) has been initiated to provide the customer without the glue.To achieve this, olympus will either rework the devices to remove the glue from the working channel or replace the devices completely.

• Brand Name: BRIDGE, ONE WAY
• Type of Device: BRIDGE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 5951367
• MDR Text Key: 54765195
• Report Number: 2951238-2016-00739
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 162W -0085
• Device Catalogue Number: A20976A
• Device Lot Number: 162W -0085
• Other Device ID Number: 04042761020398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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