MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW 4 RACHETED HANDPIECE, 34CM; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3914
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to a lack of communication, this advesre event occured on (b)(6) 2022 but was not reported to microline surgical, inc.Until (b)(6) 2023.Since this event happened over a year ago, the device that was used is not available for testing and a full investigation could not be completed.However, a corrective action for events related to a detached heat shrink was created in march of 2023.The corrective action specifies that the work instructions would be updated to clarify the heat shrink process, the heat shrink oven parameters would be updated for clarity, and it would be specified that the oven door should not be left open for more than 10 seconds.Although testing of the actual device can not be done, the final results for this adverse event fall under the corrective action that microline surgical, inc.Currently has open for similair reports (car-0171).
Event or Problem Description
During the laparoscopy technique in a inguinal hernia procedure, a piece of the plastic cover that covers this clamp removed, remaining inside the patient.The anesthesist observed a foreign body on the screen and alerted the surgeons who removed it.

• Brand Name: RENEW 4 RACHETED HANDPIECE, 34CM
• 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: 17984723
• Report Number: 1223422-2023-00034
• Device Sequence Number: 8398360
• Product Code: GEI
• UDI-Device Identifier: 00811099010579
• UDI-Public: 00811099010579
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: 962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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: 3914
• Device Catalogue Number: 3914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Seven-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown