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

Model Number	A20976A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus representative reported on behalf of the customer, during a procedure, the bridge was swiveling during a case.After the procedure, at reprocessing, it was noted the bridge unscrewed apart.The two pieces of the bridge were dismantled and bioburden, possibly crusted blood, was found in the bridge.The facility took apart the other six (6) bridges and bioburden was found on the other six (6) bridges as well.No patient harm reported.This complaint is related to patient identifiers: (b)(6).
Additional Manufacturer Narrative
Model #: 167 - 0103 or 162 - 0103 or 16z - 0103.Lot number was partially illegible.In speaking with olympus technical support via the phone, no troubleshooting was performed.The olympus representative stated the customer requested feedback from olympus on how to move forward, now that this bioburden was found inside the devices.The facility had owned the sets for multiple years and never disassembled them as the process was not indicated in the instructions for use.Since the issue had occurred, the facility had removed the bioburden from each bridge and were taking the bridges apart for each procedure to ensure the bridges were clean.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This is a supplemental report to correct the initial mdr (9610773 - 2022 - 00224).Upon further review, it was determined this complaint/report is a duplicate of mfr report number # 9610773 - 2022 - 00223.

• Brand Name: BRIDGE, ONE WAY
• Common Device Name: BRIDGE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14736213
• Report Number: 9610773-2022-00224
• Device Sequence Number: 2226868
• Product Code: GCP
• UDI-Device Identifier: 04042761020398
• UDI-Public: 04042761020398
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A20976A
• Device Catalogue Number: A20976A
• Device Lot Number: 167 - 0103 OR 162 OR 16Z
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown