MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRESSEW III AC+ GUN; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 288233

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Unintended Movement (3026)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

It was reported by the affiliate in colombia that the expressew iii ac+ gun device did not deploy normally, and had slightly loose jaws and wear marks.There was no procedure nor patient involvement reported.No additional information was provided.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection was found wear use in the entire device.The laser etch were slightly faded.It could be observed the upper jaw was found loose.Finally, it was found trying to load the needle to the expressew, it was get stuck at the moment to pass it through the shaft.The functional test cannot be performed due to the condition of shaft for the needle load procedure.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 results, this complaint can be confirmed.The possible root cause for the condition of the device could be attributed to an improper maintenance during cleaning/ sterilization cycle would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.For the condition of the jaw can be attributed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually damage the jaw.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, it cannot be conclusively affirmed.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function and do not use if product is damaged.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-soluble lubricant in accordance with the manufacturer¿s instructions.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: EXPRESSEW III AC+ GUN
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 3035526892
• MDR Report Key: 14455592
• MDR Text Key: 292503752
• Report Number: 1221934-2022-01469
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 288233
• Device Catalogue Number: 288233
• Device Lot Number: 46650-180116-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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