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

Model Number	3221
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The tip broke off into the abdomen of the patient.
Additional Manufacturer Narrative
At this time, microline surgical is waiting to hear back from the end user regarding more details about the event.Once msi has more information and if the device is available for an investigation, a final report will be submitted.
Event or Problem Description
The tip broke off in the abdomen of the patient.
Additional Manufacturer Narrative
The device was returned, decontaminated, and subjected to a visual inspection.Upon evaluation, the complaint was confirmed due to the presence of a broken jaw.Initially, the complaint was reported with an unknown lot number.The device was examined under a microscope to identify the lot number and assess for additional damage.Microscopic analysis revealed wear and tear on the heat shrink, along with markings consistent with repeated contact with other instruments and/or excessive reprocessing.The lot number was identified as 00140578, which corresponds to a manufacturing date in 2018.According to the renew reusable laparoscopic instrument tip instructions for use (ifu), the device is validated for 25 sterilization cycles, but due to its design and materials, it is not possible to define an exact maximum number of reprocessing cycles.The device's age suggests it may have exceeded its intended lifespan, potentially compromising material strength, particularly in the jaw slot area.Additionally, per dcaf-0282, a design change was implemented to increase the tang radius of the fenestrated jaw slots, improving torsional bending strength.These changes were made as a preventative measure and do not introduce any new risks.The device in question was manufactured prior to this design update.The likely root cause of the jaw damage is a combination of the device's age, potential overuse beyond validated reprocessing limits, and the absence of the improved jaw slot design introduced in later manufacturing.

• Brand Name: RENEW FENESTRATED GRASPER TIP, REUSABLE
• 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 01915 ; 9789229810
• MDR Report Key: 22152435
• Report Number: 1223422-2025-00016
• Device Sequence Number: 9208933
• Product Code: GEI
• UDI-Device Identifier: 00811099011651
• UDI-Public: 00811099011651
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K974066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 3221
• Device Catalogue Number: 3221
• Device Lot Number: 00140578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown