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

Model Number	218019
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that the o-rings of the inflow/outflow sheath system keeps coming off.No procedure was involved at the time of the failure.The devices are available to be returned for evaluation.
Additional 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.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.
Additional 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.Investigation summary complaint description: it was reported by the sales rep via phone that the o-rings of the inflow/outflow sheath system keeps coming off.No procedure was involved at the time of the failure.The devices are available to be returned for evaluation.Investigation summary: the device was returned and inspected.Upon visual inspection, there were no physical damage was noticed.The device was disassembled, all red o-rings were found to be on their placed.The complete functional testing cannot be performed since whole system setup is not available.The complaint cannot be replicated/confirmed for the fell apart reported condition.However, the knob/handle of the device was found to be bent.A manufacturing record evaluation was performed for the finished device [151001] number, and no non-conformances were identified.Based on given the information provided we cannot discern a definitive root cause for the reported failure.For bent condition it is possible that the device was been dropped or the device experienced excessive force.At this time, 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.

• Brand Name: I/O FLOW SHEATH-S&N
• Common Device Name: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10311771
• Report Number: 1221934-2020-01874
• Device Sequence Number: 16948281
• Product Code: NBH
• UDI-Device Identifier: 10886705023721
• UDI-Public: 10886705023721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2020

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: 218019
• Device Catalogue Number: 218019
• Device Lot Number: 151001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/11/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/12/2020
• Patient Sequence Number: 1