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

Model Number	3362
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, msi is awaiting the device back so an investigation can be conducted.Once an investigation occurs, a final report will be submitted with all findings.
Event or Problem Description
The shrink wrap fell off in the patient and they were able to recover it fully.

• Brand Name: RENEW HUNTER GASPER 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: 19667015
• Report Number: 1223422-2024-00024
• Device Sequence Number: 20561413
• Product Code: GEI
• UDI-Device Identifier: 00811099013860
• UDI-Public: 00811099013860
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 3362
• Device Catalogue Number: 3362
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/03/2024
• 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
• Patient Sex: Unknown