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

Model Number 3100-D

Device Problem Residue After Decontamination (2325)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.

Event 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.

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 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
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10116426
• MDR Text Key: 194305358
• Report Number: 0008031020-2020-01534
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327356168
• UDI-Public: 07613327356168
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3100-D
• Device Catalogue Number: 3100-D
• Device Lot Number: 01469
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR