MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL OBT_BUTTON_4.0,167CW_MITEK; RIGID ENDOSCOPE OBTURATOR

Model Number 242258

Device Problem Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that the dual stopcock sheath 5.9 mm x 30 deg x 167 mm (mitek lock) and the obturator with button top for 5.9 mm sheath 167 mm (mitek lock) are bent and difficult to slide in.No procedure or patient involvement.The devices are available to be returned for evaluation.

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: according to the information provided, it was reported that the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) and the obturator with button top for 5.9mm sheath 167mm (mitek lock) are bent and difficult to slide in.The complaint device was received and evaluated.Visual inspection revealed that the device had signs of nicks and striation marks on the surface of the distal end of the tube it also appears to be considerably used and is in worn condition.The functional test was performed as a result, there was a resistance when assembled both pieces; this condition may contribute to generate to stuck issue.The 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 a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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: OBT_BUTTON_4.0,167CW_MITEK
• Type of Device: RIGID ENDOSCOPE OBTURATOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10645518
• MDR Text Key: 210427220
• Report Number: 1221934-2020-02905
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705029174
• UDI-Public: 10886705029174
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 242258
• Device Catalogue Number: 242258
• Device Lot Number: 1487384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/13/2020
• Patient Sequence Number: 1