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

Model Number 242025

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

It was reported by the customer that during an unknown arthroscopy procedure on (b)(6) 2022, it was observed that the o-ring on the she_2rstck_5.9,30,167cw_ mitek device was loose.According to the report, the surgeon tried to tighten the o-ring but the entire sheath fell apart.It was further reported that the surgeon stated that the sheath or the trochanter ¿felt bent¿ as it did not slide smoothly.The procedure was completed successfully.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Additional narrative: udi: (b)(4).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.

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: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed the device had wear marks indicating it was heavily used in the field.The device was found with a lot of scratches in the entire tubing.The distal part of the shaft appeared to be deformed.Finally, the mitek lock is not attached in the device and wear marks were identified near the connection points.The bent shaft might have contributed to the reported unable to disassemble condition.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Based on the visual inspection of the device, this complaint can be confirmed.The possible root cause for the reported failure can be related when the device might have been dropped or device was tapped against a hard surface accidentally, as well as rough use by the user.As per ifu, do not use a damaged or defective endoscope.Inspect the endoscope prior to each examination or procedure and before sterilization based on the instructions in this document; it is important to check the shaft for bending, scratches, dents, corrosion, pitting, or other surface irregularities.Do not hold the endoscope by its shaft; this may cause damage and do not bend the endoscope or subject the endoscope to impact.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

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.

• 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: 13637481
• MDR Text Key: 288199386
• Report Number: 1221934-2022-00668
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• 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: 1525883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• 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