MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW FENESTRATED GRASPER FORCEPS TIPS; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is pending the return of the device.
Event or Problem Description
When grasping a very thick-walled gallbladder, a ""branch"" of the grasping forceps broke off, landed behind the liver, was localized by x-ray, and was easily removed laparoscopically.The rest of the operation was unproblematic.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually inspected.It was returned with a broken bottom jaw near the hinge point.Upon visual inspection, this complaint is confirmed.Because of the condition of the returned device, a functional test was not possible.The type of damage observed may be the result of excessive force or stress applied to the tip of the device.If the jaws of the device are activated on hard material or used outside of their intended use, they may be compromised.It is unlikely that the device left microline inc in this condition, because all devices are 100% inspected for damages and imperfections.This is an uncommon issue in the field, the first occurrence this year (2020).The most probable root cause may be attributed to an excessive force applied to the jaws.This is a known issue with this device.A corrective action is in progress to strengthen the jaw and eliminate the issue.This action should be completed by the end of october 2020.
Event or Problem Description
When grasping a very thick-walled gallbladder, a ""branch"" of the grasping forceps broke off, landed behind the liver, was localized by x-ray, and was easily removed laparoscopically.The rest of the operation was unproblematic.

• Brand Name: RENEW FENESTRATED GRASPER FORCEPS TIPS
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 10520242
• Report Number: 1223422-2020-00007
• Device Sequence Number: 2757431
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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 Expiration Date: 02/28/2025
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00151283
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 120