MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A20977A

Device Problems Break (1069); Detachment Of Device Component (1104); Flaked (1246); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/23/2016

Event Type  malfunction  

Event Description

Brief description of event: after insertion of a 0.35 guide wire down the neck of the working port of the resectoscope bridge, the surgeon proceeded to pass a 5 french catheter over the guide wire.Upon advancing the catheter the surgeon spotted a brown clump in the urethra.The resectoscope was examined in sterile processing and found that the weld in the bridge contains a brown glue type binder that covers the welded area in the bridge and it was missing pieces that cover the weld.Brief description of problem: adhesive used in the instrument construction is coming off and may be retained in the patient.When glue inside of the bridge deteriorates, it results in the glue flaking off and potentially leaves pieces with sharp edges in patients.It can also affect bristles on a brush which can be left in the bridge after reprocessing.Brief description of solution: working closely with the manufacturer on this issue.The manufacturer has confirmed that the glue is not stable and countermeasures are needed.The manufacturer will remove the glue from manufacturing of the devices and replace all our bridges.

Manufacturer Narrative

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Event Description

Brief description of event: after insertion of a 0.35 guide wire down the neck of the working port of the resectoscope bridge, the surgeon proceeded to pass a 5 french catheter over the guide wire.Upon advancing the catheter the surgeon spotted a brown clump in the urethra.The resectocope was examined in sterile processing and found that the weld in the bridge contains a brown glue type binder that covers the welded area in the bridge and it was missing pieces that cover the weld.Brief description of problem: adhesive used in the instrument construction is coming off and may be retained in the patient.When glue inside of the bridge deteriorates, it results in the glue flaking off and potentially leaves pieces with sharp edges in patients.It can also affect bristles on a brush which can be left in the bridge after reprocessing.Brief description of solution: working closely with the manufacturer on this issue.The manufacturer has confirmed that the glue is not stable and countermeasures are needed.The manufacturer will remove the glue from manufacturing of the devices and replace all our bridges.

• Brand Name: OLYMPUS
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6529299
• MDR Text Key: 73938460
• Report Number: 6529299
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/27/2017,04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: A20977A
• Device Catalogue Number: A20977A
• Device Lot Number: MULTIPLE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1