MAUDE Adverse Event Report: MICROLINE SURGICAL INC. CONTROL TIP ATRAUMATIC FENESTRATED FORCEPS TIP; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3642
Medical Device Problem Codes	Material Fragmentation (1261); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a late mdr report.The device will be investigated upon return to microline surgical inc.
Event or Problem Description
During a surgical procedure, the heat shrink from a renew super atraumatic grasper tip was found within the stomach cavity of the patient.It is unknown, if the fallen heat shrink was retrieved.
Additional Manufacturer Narrative
This is a late mdr, which was due on (b)(6) 2018.The device was returned, decontaminated, and visually investigated.The device with undamaged tip, is reported with this mdr-00025.The second tip was returned with a defective heat shrink is reported in mdr, ref.(b)(4).The tip was attached to a functional hand-piece for functionality testing.The tip worked as intended.No defects was observed.There were no signs of physical damages, or wear and tear to the device.For additional testing the tip was attached to an insulation tester, and passed with no issue.No defects to the insulation were noted on the heat shrink, back hub or their connections.The complaint is unconfirmed.No additional complaints were reported with these lot numbers.The root cause could not be determined.
Event or Problem Description
During a surgical procedure, a piece of heat shrink from a renew super atraumatic grasper tip, was seen in the stomach cavity of a patient during the final inspection.The heat shrink piece was retrieved.The procedure and anesthesia time were not extended.There was no harm to the patient.

• Brand Name: CONTROL TIP ATRAUMATIC FENESTRATED 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: 7810611
• Report Number: 1223422-2018-00025
• Device Sequence Number: 1052840
• Product Code: GEI
• UDI-Device Identifier: 00811099010166
• UDI-Public: 00811099010166
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 3642
• Device Catalogue Number: 3642
• Device Lot Number: 00138147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1