MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW MODIFIED MARYLAND DISSECTOR TIP, DISPOSABLE; MANUAL SURGICAL DETACHABLE INSTRUMENTS

Model Number	3222
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to microline surgical, inc.Once the device is returned, an investigation will be performed.
Event or Problem Description
The heat shrink portion of the disposable tip came off in the abdominal cavity.The piece was able to be retrieved.There was no harm to the patient.

• Brand Name: RENEW MODIFIED MARYLAND DISSECTOR TIP, DISPOSABLE
• Common Device Name: MANUAL SURGICAL DETACHABLE INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8363443
• Report Number: 1223422-2019-00003
• Device Sequence Number: 19409840
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00143494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention