MAUDE Adverse Event Report: MICROLINE SURGICAL INC. M/L-10 CLIP CARTRIDGE, 10 CLIPS, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	1122
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident was reported to the national competent authority of spain.Manufacturer is trying to obtain additional information from the user facility and distributor.The device has not been returned for an investigation.
Event or Problem Description
The theatre supervisor describes: in a cholecystectomy requiring 3 or 4 clips, surgeons have gone as far as using 10, the clips do not close properly.

• Brand Name: M/L-10 CLIP CARTRIDGE, 10 CLIPS, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 13942427
• Report Number: 1223422-2022-00001
• Device Sequence Number: 17341516
• Product Code: GCJ
• UDI-Device Identifier: 00811099010463
• UDI-Public: 00811099010463
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013695
• 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): 03/29/2022

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: 1122
• Device Catalogue Number: 1122
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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