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

Model Number	3352
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual inspection, this complaint has been confirmed.The tip was returned with a loose heat shrink.Because the condition of the returned tip, an insulation and functional test could not be conducted on the returned tip.The heat shrink is damaged from the distal end to the tip.No signs of arcing or thermal damages were noted on the device.The minor damages observed on the heat shrink, line up very close to the hinge point of the jaws.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.This complaint is confirmed.Unable to determine the root cause.A possible root cause may be due to the device contacting with another instrument.
Event or Problem Description
While performing a laparoscopic cholecystectomy, the surgeon noticed that the heat-shrink on the renew traditional maryland dissector forceps tip was no longer there.The heat-shrink fell off the tip into the patient.The surgeon and the scrub nurse were able to locate the entire heat-shrink piece and retrieve it.The procedure and anesthesia time were not extended.There was no harm to the patient.

• Brand Name: RENEW TRADITIONAL MARYLAND DISSECTOR FORCEPS TIP
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7526194
• Report Number: 1223422-2018-00013
• Device Sequence Number: 19188709
• Product Code: GEI
• UDI-Device Identifier: 00811099010135
• UDI-Public: 00811099010135
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 11/28/2022
• Device Model Number: 3352
• Device Catalogue Number: 3352
• Device Lot Number: 00138306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1