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

Model Number	3262
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned to microline surgical, inc.If the device is returned an investigation will be performed and additional information will be provided.
Event or Problem Description
On (b)(6) 2019, during a laparoscopic sigmoid colectomy, the heat shrink on a 3262 long fenestrated disposable grasper came off during the procedure and had to be retrieve from the patient's abdomen by surgeon.

• Brand Name: RENEW LONG FENESTRATED GRASPER 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: 9171871
• Report Number: 1223422-2019-00027
• Device Sequence Number: 2323690
• Product Code: GEI
• UDI-Device Identifier: 00811099010081
• UDI-Public: 00811099010081
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: 06/28/2024
• Device Model Number: 3262
• Device Catalogue Number: 3262
• Device Lot Number: 00147450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1