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

Model Number 218019

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4) incomplete.The lot number was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a shoulder scope the inflow/outflow sheath system (b)(4) was leaking.Another device was used to complete the procedure.No patient consequences or surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary
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> complaint description; it was reported by the sales rep via phone that during a shoulder scope the inflow/outflow sheath system (smith & nephew) was leaking.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device(s) is/are available for evaluation.Investigation summary: the complaint device was received and inspected.It was observed that the outflow lever(blue color) was broken off the outflow switch.The complaint can be confirmed as broken switch would have caused the reported failure.It is possible that excessive force was applied to the outflow lever during use, therefore causing it to break off the switch.However, given the information provided we cannot discern a definitive root cause for the reported failure.A manufacturing record evaluation was performed for the finished device [151001] number, and no non-conformances were identified.Therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information (d4): lot number was updated.Udi: (b)(4).

• Brand Name: I/O FLOW SHEATH-S&N
• Type of Device: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10212115
• MDR Text Key: 197096046
• Report Number: 1221934-2020-01713
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705023721
• UDI-Public: 10886705023721
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2020

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: 218019
• Device Catalogue Number: 218019
• Device Lot Number: 151001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 07/15/2020; 07/15/2020; 07/28/2020
• Supplement Dates FDA Received: 07/16/2020; 07/22/2020; 07/29/2020
• Patient Sequence Number: 1