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 with in the stomach cavity of the patient.The heat shrink was retrieved from the patient.
Additional Manufacturer Narrative
This is a late mdr, which was due on 09/26/2018.The device was returned, decontaminated and visually investigated.Upon visual investigation, this complaint is confirmed.Two tips were returned in the same bag (see 1223422-2018-00025).Unable to determine the exact lot number of the two.One of the two tips was returned with a defective heat shrink.The tip was returned with damages on the heat shrink around the hinge point of the device.It is possible that during surgery the heat shrink may have slid up to the hinge point, so much so that when the device was activated, the hinge point compromised the heat shrink material, causing it to deform.No additional complaints were reported with these lot numbers.A 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: 7810613
• Report Number: 1223422-2018-00026
• Device Sequence Number: 13972128
• 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: 01/28/2023
• Device Model Number: 3642
• Device Catalogue Number: 3642
• Device Lot Number: 00138919
• 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