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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: according to the information provided, it was reported that prior to an unknown surgery it was noticed that obturator with button top for 5.9mm sheath 167mm (mitek lock) is stuck in the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock); sheath will not release.The complaint device was received for evaluation.Upon visual inspection, it was found that the obturator is jammed inside the sheath, the end of the sheath shaft is deformed.A manufacturing record evaluation was performed for the finished device 1494067 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for this issue can be attributed to procedural variables, such handling of the device or product interaction during procedure, since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to damages on the sheath, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by sales rep that prior to an unknown surgery on (b)(6) 2021, it was observed that the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) device was stuck with and would not release from the obturator.During in-house engineering evaluation, it was determined that an obturator was jammed inside the sheath; and with the end of the sheath shaft being deformed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13010534
• MDR Text Key: 286767112
• Report Number: 1221934-2021-03754
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705029013
• UDI-Public: 10886705029013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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: 1494067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/15/2021
• Date Device Manufactured: 03/09/2018
• 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