MAUDE Adverse Event Report: STRYKER GMBH ENDOTRAC EPF-D; ACCESSORIES, ARTHROSCOPIC

Model Number	3100-D
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It was reported: we were using epf xpress.The doctor put a cotton swab through the cannula (while in the patient) in order to clear soft tissue.When the cotton swab came out there was a perfect black circle on it.This happened 4 more times.
Additional Manufacturer Narrative
The reported event that an endotrac epf-d was alleged of " dirt/residue" could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: we were using epf xpress.The doctor put a cotton swab through the cannula (while in the patient) in order to clear soft tissue.When the cotton swab came out there was a perfect black circle on it.This happened 4 more times.

• Brand Name: ENDOTRAC EPF-D
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10116426
• Report Number: 0008031020-2020-01534
• Device Sequence Number: 1762107
• Product Code: NBH
• UDI-Device Identifier: 07613327356168
• UDI-Public: 07613327356168
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 3100-D
• Device Catalogue Number: 3100-D
• Device Lot Number: 01469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR