MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW LAPCLINCH GRASPER TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3252
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Grasper piece was attached to handpiece and inserted into patient.When surgeon activated grasper to open, the grasper broke and a piece of grasper fell into the patient.Surgical/anesthesia time was extended by five minutes and an x-ray was done to ensure all foreign material was removed from the patient.
Additional Manufacturer Narrative
An investigation was performed of the reported issue of scissor tip broke off failure mode and it was confirmed.Customer reported the unit to be p/n 3252 from lot number 00170850.Summary of investigation can be found below.Investigation was performed by sr.Quality engineer.Manufacturing process was reviewed, there are no normal manufacturing conditions in it that would result in scissor tip broke off as the one reported.No sample was available, however there was a picture that was used for this investigation.It can be seen that slot broke (see figure 2.Broken slot).There is a capa initiated for the reported failure mode, it is car-0161.Root cause analysis for reported failure mode and actions are dealt within previously mentioned capa (car-0161).The complaint for jaw is broken failure mode could be confirmed.

• Brand Name: RENEW LAPCLINCH GRASPER TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• 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: 21178645
• Report Number: 1223422-2024-00026
• Device Sequence Number: 4262726
• Product Code: GEI
• UDI-Device Identifier: 00811099010074
• UDI-Public: 00811099010074
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3252
• Device Catalogue Number: 3252
• Device Lot Number: 00170850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown