MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SHE_2RSTCK_5.9,30,167CW_ MITEK; ACCESSORIES, ARTHROSCOPIC

Catalog Number 242025

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported by the sales rep that the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) and obturator with button top for 5.9mm sheath 167mm (mitek lock) devices continued to get stuck together.During in-house engineering evaluation, it was determined that resistance was felt when trying to assemble and disassemble as the obturator was assembled in the sheath.There was no procedure involved.No additional information was provided.Report 1 of 2 for (b)(4).

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: d4: the date of expiration is unknown.Udi:(b)(4).Investigation summary : the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed that the device had wear marks indicating it was heavily used in the field.The device was found with scratches in distal part and near the tip.Also, the tip of the shaft and the shaft were deformed and lost its original shape.For the functional test, the obturator was assembled in the sheath; as a result, a resistance was felt when trying to assemble and disassemble.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.The manufactured date of this device is 2018 and hence indicates this device is 5 years old.Based on the test results, this complaint can be confirmed.The possible root cause for the reported failure can be related to the bent condition of the sheath; this damage in the sheath has possible occurred after use in several procedures.As per ifu- 115828, 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.

• Brand Name: SHE_2RSTCK_5.9,30,167CW_ MITEK
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18612528
• MDR Text Key: 334674847
• Report Number: 1221934-2024-00297
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2024

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 Catalogue Number: 242025
• Device Lot Number: 1525883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1