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

Model Number A20976A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

The referenced bridge a20976a was returned to olympus for evaluation.The evaluation confirmed that the adhesive was completely missing from the welding area inside the working channel of the bridge.An oem investigation is currently ongoing and if additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that the glue came out of the channel of the bridge (a20976a) during an cysto-ureteroscopy procedure.The surgeon pushed the scope through the channel of the bridge and two brown plastic like substances came out the other end.The user facility reported no device fragments fell into the patient.The bridge was replaced and the procedure was completed using a similar bridge.No patient harm/injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).The oem performed a review of the device history records and did not reveal any non-conformities for this device.The glue is used to seal a small gap inside the device.However, based on the oem¿s investigations 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 patient health, a fsca has been initiated to provide customers devices 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, ONE WAY
• 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: 6775834
• MDR Text Key: 82161858
• Report Number: 2951238-2017-00517
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20976A
• Device Catalogue Number: A20976A
• Device Lot Number: 169W-0081
• Other Device ID Number: 04042761020398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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