MAUDE Adverse Event Report: MICROLINE SURGICAL INC SUPER ATRAUMATIC GRABBER TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3622
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was done of the reported issue of heat shrink came off.Customer reported the unit to be from the lot no.00170748.Summary of investigation can be found below.Investigation was done, sr.Quality engineer and r&d engineer participated.Manufacturing process was reviewed, there are no normal manufacturing conditions in it that would result in heat shrink came off as the one reported.It can be seen that heat shrink is separate from the unit, when reviewed heat shrink appeared not to have been shrinked correctly.Customer reports that heat shrink came off.Human mistake: which resulted in the reported unit not going into the oven for shrinking or not placed correctly in the tray that goes in the oven.Root cause analysis result is considered an isolated event.We will be monitoring in case an adverse trend arises.
Event or Problem Description
Heat shrink fell off into patient abdomen-no harm to patient.

• Brand Name: SUPER ATRAUMATIC GRABBER 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: 19462144
• Report Number: 1223422-2024-00008
• Device Sequence Number: 6812861
• Product Code: GEI
• UDI-Device Identifier: 00811099010142
• UDI-Public: 00811099010142
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 3622
• Device Catalogue Number: 3622
• Device Lot Number: 00170748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 06/04/2024
• 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