MAUDE Adverse Event Report: MICROLINE SURGICAL RENEW SUPER ATRAUMATIC FENESTRATED GRASPER TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3642
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ref 3642, lot 00175971, black plastic head dropped into patient's stomach.
Additional Manufacturer Narrative
At this time, microline surgical is waiting for the device to be returned so an investigation can be completed.Once the device is returned and an investigation is complete, a final adverse event report will be submitted.
Additional Manufacturer Narrative
The renew grasper tip was received and subjected to a visual inspection.It was observed that the device had been returned without the heat shrink component attached.No additional visible signs of physical damage, wear, or other abnormalities were identified during naked-eye examination.The tip was then connected to a verified functional handpiece for performance testing.While the device functioned as intended, its overall integrity was deemed compromised due to the missing heat shrink.Therefore, the complaint is confirmed.The absence of the heat shrink component suggests that it may not have been adequately exposed to the required heat during the assembly process, resulting in poor adhesion.Microline surgical inc.Has received similar reports, prompting the initiation of a corrective action (car-0200) to investigate and address the root cause of this failure.As part of the car investigation, quality assurance implemented interim containment actions, including independent verification of heat shrink presence and adhesion prior to release for every lot manufactured on the affected assembly line.The assembly work area was reorganized to include a designated holding zone for tips that have completed the heat shrink process.Product remains in this area until it passes 100% inspection before proceeding to the next stage.Assembly work instructions were updated to include detailed guidance on performing a tactile push/pull test to verify proper heat shrink adhesion.The inspection procedure was revised to include a specific step for visual confirmation of the heat shrink application.
Event or Problem Description
A black plastic component detached and fell into the patient's abdominal cavity during the procedure.

• Brand Name: RENEW SUPER ATRAUMATIC FENESTRATED GRASPER TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, ma, MA 01915 ; 9789229810
• MDR Report Key: 22202678
• Report Number: 1223422-2025-00018
• Device Sequence Number: 6682493
• Product Code: GEI
• UDI-Device Identifier: 00811099010166
• UDI-Public: 00811099010166
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 07/30/2025

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: 3642
• Device Catalogue Number: 3642
• Device Lot Number: 00175971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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