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

Model Number 242025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.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 affiliate in (b)(6) that during a meniscus arthroscopy procedure on an unknown date, it was observed that the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) device failed as it damaged the meniscus due to its design.The procedure was completed without major complications.The status of the patient post-surgery was unknown.No additional information was provided.

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.Subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the date of event and event description have been updated accordingly.D4: the lot number was reported as unknown on the initial report; and has been updated accordingly.Therefore, udi: (b)(4).

Event Description

It was reported by the affiliate in chile that during a meniscus arthroscopy procedure on (b)(6) 2021, it was observed that the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) device failed as it damaged the meniscus due to its design.According to the report, the device had a very aggressive shirt and millimeter longer than the optic that it broke the meniscus.The procedure was completed without major complications.The status of the patient post-surgery was unknown.No additional information was provided.

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: investigation summary : the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (1534854), and no non-conformance was identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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: 12051825
• MDR Text Key: 257841414
• Report Number: 1221934-2021-01967
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 242025
• Device Catalogue Number: 242025
• Device Lot Number: 1534854
• Initial Date Manufacturer Received: 06/12/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/25/2021; 07/21/2021
• Supplement Dates FDA Received: 06/28/2021; 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention