MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SHE_2RSTCK_5.9,30,167CW_ MITEK; RIGID ENDOSCOPE SHEATH

Model Number 242025

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.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 testing, it was observed that the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) device was were extremely tight, and the obturator can barely fit.This event did not occur during surgery.There was no 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.

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 : according to the information provided, it was reported that the dual stopcock sheath was extremely tight and the obturator can barely fit.The device was received and evaluated.When performing the visual inspection, a straight ruler was used to review the device tube for bending, it was found that the device is slightly bent at the distal end.The lateral valves can be opened and closed with no restriction.The mitek lock button is in its place as expected.According with the visual inspection result, we can confirm this complaint.A possible root cause can be attributed to the handling of the device, since this device is reusable, the metal parts are expected to have some structural changes due to rough and repeated use and sterilization process.However, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device [serial number : (b)(6)], and no non-conformances were identified.At this point in 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: SHE_2RSTCK_5.9,30,167CW_ MITEK
• Type of Device: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10879323
• MDR Text Key: 217681911
• Report Number: 1221934-2020-03563
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705029013
• UDI-Public: 10886705029013
• 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
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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: 242025
• Device Catalogue Number: 242025
• Device Lot Number: 1488593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1