MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW MICROSCISSOR TIP, DISPOSABLE; FLEXIBLE ENDOSCOPIC SCISSORS, SINGLE-USE

Model Number	3122
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical, inc is awaiting the affcted tip back from the importer/distributor.An investigation will be conducted, and a final adverse event report will be submitted with the results.
Event or Problem Description
The heat shrink got caught on the trocar and came off and retrieved.It did not fall into the abdominal cavity.
Additional Manufacturer Narrative
In response to the recent inquiries from amco incorporated, pertaining to heat shrink falling off of microline surgical inc.'s renew disposable tips (cat#: 3112), we have received the complaints.We apologize for any inconvenience that this issue may have caused.Microline surgical inc.Has initiated a voluntary recall on all parts of affected lot: 00172110 (cat#: 3122) and issued a corrective action (car-0200) to address this problem.Other immediate containment carried out by microline surgical inc.Included inspecting all grasper tips in process and in our stockroom for this defect.Additionally, our quality assurance team performed an independent verification of heat shrink prior to release for every lot of tips being manufactured on the affected assembly line until the car investigation was complete.The root cause identified through the investigation of car-0200 was that the tips were not processed in accordance with the work instruction.The parts were not subjected to elevated temperature in an oven as the assembly process calls for.Therefore, the heat shrink did not firmly attach to the tip assemblies.When investigating further the following factors were identified as contributing to the process failure: the state of work of material was not properly identified during break times and the end of the day.The work area had no visible staging area to identify status of parts (awaiting oven versus already processed through oven).Insufficient inspection and training of operators.The oven process log does not include the number of tips processed.There is no method to reconcile if all parts were placed in the oven.For the implementation stage of car-0200 the assembly line work area was rearranged to provide a separate holding area for tips processed through the heat shrink oven.Product is held in this area until it is 100% inspected and released for further processing.Our assembly work instruction was updated to include more detail on how to perform a tactile pull/push test which will ensure the heat shrink is secure.Our inspection procedure was revised to include a step on visually examining the shrunk tubing.A step was also added to our packaging work instruction as another level of verifying that the heat shrink is firmly attached.Lastly, the oven process log used in tip assembly was revised to record the quantity of tips processing through the oven.All operators have been trained to the updated procedures.Car-0200 is currently in the verification stage where we will ensure the improvements implemented are still being practiced and we will monitor customer complaints for this defect.
Event or Problem Description
The heat shrink got caught on the trocar and came off and retrieved.It did not fall into the abdominal cavity.

• Brand Name: RENEW MICROSCISSOR TIP, DISPOSABLE
• Common Device Name: FLEXIBLE ENDOSCOPIC SCISSORS, SINGLE-USE
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 20798320
• Report Number: 1223422-2024-00044
• Device Sequence Number: 15424494
• Product Code: GEI
• UDI-Device Identifier: 00811099010036
• UDI-Public: 00811099010036
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: Health Professional
• Device Model Number: 3122
• Device Catalogue Number: 3122
• Device Lot Number: 00172110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown