MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW TRADITIONAL MARYLAND DISSECTOR TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3352
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation will be performed upon return of product to microline surgical, inc.
Event or Problem Description
Protective sleeve on tip came off during procedure and had to be removed from patient.
Event or Problem Description
Protective sleeve on tip came off during procedure and had to be removed from patient.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual inspection, this complaint has been confirmed.The returned tip was returned with a defective heat shrink.The device was returned with a heat shrink that looked to have receive unintentional forces from both ends, causing the middle of the heat shrink to extrude.This may be the result of the heat shrink not being fully recovered during the assemble process.There is a slight gap between the heat shirk and back hub that may also imply that the heat shrink was not fully recovered.Unable to determine if that was the result of the defect, or the root cause of the reported issue.If the heat shrink was not fully recovered it is very possible that the device may have gotten caught on or in between another device, which would then cause movement to the heat shrink while still connected to the the grasper, hence the extrusion.Because of the condition of the returned device, a functional test is not possible.The type of defects noted on the heat shrink is very uncommon.For final inspection requirements, all devices are 100% inspected for damages and imperfections.It is not likely that the device left microline inc in this condition.The type of damages observed are the result of excessive force applied on a heat shrink that may have not been fully recoved.This complaint is confirmed.A device complaint history check was conducted on part number 3352 from this corresponding lot, and there have been zero additional complaints from this lot within the past year.Although there has been similar complaint from this part number, this is an isolated incident for this lot.The defect rate for this complaint is extremely low.

• Brand Name: RENEW TRADITIONAL MARYLAND DISSECTOR TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8322180
• Report Number: 1223422-2019-00001
• Device Sequence Number: 1357415
• Product Code: GEI
• UDI-Device Identifier: 00811099010135
• UDI-Public: 00811099010135
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 12/28/2022
• Device Model Number: 3352
• Device Catalogue Number: 3352
• Device Lot Number: 00138532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1