MAUDE Adverse Event Report: MEIXEN MEDICAL SUZHOU CO., LTD. 30-101 KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4" IN FOAM HOLDER 5/P; LAPAROSCOPIC BLUNT DISSECTOR

Model Number	30-101
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause from vendor indicates there is an attached thread on the product.It is possible that the "falling apart" problem may happen because that the sewing of the sponge was not solid enough or that when the workers try to trim the thread, they wrongly cut the key fix thread, and cause the sponge to fall apart.Corrective action: supplier corrective action request (scar) was completed ((b)(6) 2021) by supplier ( (b)(4) ltd.) to advise workers to check sponges to find whose sewing is not meeting standard.Then instruct the correct sewing method to them and tighten the quality inspection on the products made by them.Sewing of the sponge shall strictly follow the steps in the product diagram.If any attached threads need to be trimmed subsequently, carefully cut the redundant threads avoiding the key fix threads to prevent the sponge falling apart problem.If any loose sponges are found during the inspection and packaging process, scrap them immediately to ensure no nonconforming products escaped.Preventive action: as per vendor ( (b)(4) , ltd.) is instruct the intended purpose of the products to the workers to enhance their quality awareness.Notify the complaint content to all workers and paste the complaint picture in the workshop for early warning purpose.Investigation: no manufacturing issue has been found.Process records could not be reviewed because there was no lot number had been indicated by the customer.However inventory check has been performed, evaluation of 6 cases have been randomly inspected and no loose ends have been found.A total of (b)(4) packs of product for the part under complaint have been sold from (b)(6) 2019 through (b)(6) 2021.Three similar issues related to the performance of the product have been reported during the same period of time.The percentage of issues equals to (b)(4) of complaints as compared to selling unit of measure.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
A physician complaint of the kittner sponge, 30-101.The physician shared that they are falling apart and potentially leaving pieces product in the patient.

• Brand Name: 30-101 KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4" IN FOAM HOLDER 5/P
• Common Device Name: LAPAROSCOPIC BLUNT DISSECTOR
• Manufacturer (Section D): MEIXEN MEDICAL SUZHOU CO., LTD.; no. 81 tuncun xi road; tuncun ind. zone; tongli town, wujiang district, suzhou 21521 6; CH 215216
• MDR Report Key: 11569152
• Report Number: 3010452421-2021-00003
• Device Sequence Number: 14317650
• Product Code: GDY
• UDI-Device Identifier: 00749756024396
• UDI-Public: 00749756024396
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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
• Operator of Device: No Information
• Device Model Number: 30-101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1