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

Model Number	3222
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
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 returned tip was returned with a defective heat shrink.In the visual inspection, physical damages were seen, and it appears that the tip was reprocessed.An extensive search of the complaint data base was conducted on the associated lot number.No additional complaints were reported with this lot number.This was an isolated incident.For final inspection requirements, all devices are 100% inspected for damages and imperfections.It is not likely that the device left microline surgical, inc.In this condition.A root cause could not be determined.
Event or Problem Description
At the end of a hysterectomy procedure, the surgeon noticed that a fragment of the heat shrink insulation tube fell into the patient's peritoneal cave.The fragment was able to be retrieved.The procedure and anesthesia time were extended for an unknown amount of time.There was no harm to the patient.

• Brand Name: RENEW FENESTRATED GRASPER 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: 7654785
• Report Number: 1223422-2018-00016
• Device Sequence Number: 122218
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: Physician
• Device Expiration Date: 07/28/2022
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00135947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR