MAUDE Adverse Event Report: DEPUY MITEK LLC US I/O FLOW SHEATH-STORZ; RIGID ENDOSCOPE SHEATH

Catalog Number 218023

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.The device appeared to be in good condition with the exception of minor scratches along the surfaces.The device was attached to running fluid to verify the leakage location on the device.No leaks were observed when the running fluid was connected to the inflow and outflow ports.Since the failure experienced by the customer could not be reproduced, no root cause is available for the reported failure.At this point, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

This is report 1 of 3 for the same event.It was reported by the affiliate in (b)(6) that during shoulder arthroscopy, it was observed that three i/o flow sheath-storz devices were leaky even though they changed the o-rings.There was a three-minute delay in the surgical procedure.There was a competitor device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: I/O FLOW SHEATH-STORZ
• Type of Device: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 9122460
• MDR Text Key: 208368553
• Report Number: 1221934-2019-58536
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705023738
• UDI-Public: 10886705023738
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2018

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 Catalogue Number: 218023
• Device Lot Number: 160901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 09/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1