MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW BABCOCK GRASPER TIP, 10MM, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3382
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device will not be returned to the manufacturer.Therefore, an investigation cannot be performed.There are no other complaints for this lot or model number.
Event or Problem Description
A piece of heat shrink became detached from the tip and fell into the patient.The piece was retrieved.

• Brand Name: RENEW BABCOCK GRASPER TIP, 10MM, 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: 11038693
• Report Number: 1223422-2020-00009
• Device Sequence Number: 1034654
• Product Code: GEI
• UDI-Device Identifier: 00811099011026
• UDI-Public: 00811099011026
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 01/28/2025
• Device Model Number: 3382
• Device Catalogue Number: 3382
• Device Lot Number: 00150667
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1