MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW FENESTRATED GRASPER TIP, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3221
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation will be performed once the device is received.This is a known issue, and a corrective action is in the process of being implemented to prevent this issue.
Event or Problem Description
During a procedure, the jaw broke and fell into the patient.The piece was retrieved.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually inspected.Upon visual inspection, this complaint is confirmed.The device was returned with its jaw broken.Because of the condition of the returned tip, a full functional test was not possible.The device was examined under a microscope.Upon this additional visual investigation, it was noted that the device was broken at the yoke.This type of damage is typically the result of an excessive force applied onto the jaws of the device.As part of msi's final inspection requirements, all devices are 100% inspected for damages and imperfections.It can be concluded that it is very unlikely that the device left microline inc in this condition.This is a known issue.As part of msi's continual improvement program, a design change to reduce the risk of breakage is currently in process.
Event or Problem Description
During a procedure the jaw broke and fell into the patient.The piece was retrieved.

• Brand Name: RENEW FENESTRATED GRASPER TIP, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 10730295
• Report Number: 1223422-2020-00008
• Device Sequence Number: 1679458
• Product Code: GEI
• UDI-Device Identifier: 00811099011651
• UDI-Public: 00811099011651
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K974066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Model Number: 3221
• Device Catalogue Number: 3221
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1