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

Model Number	3352
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product was not returned to microline surgical and no investigation could be performed.
Event or Problem Description
During a laparoscopic tep/hernia procedure, the heat shrink detached and fell into extra peritoneal space.Extended op time because one had to search/find and get out the detached part.

• Brand Name: RENEW TRADITIONAL MARYLAND DISSECTOR 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: 12364358
• Report Number: 1223422-2021-00005
• Device Sequence Number: 14437878
• Product Code: GEI
• UDI-Device Identifier: 00811099010135
• UDI-Public: 00811099010135
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 07/28/2024
• Device Model Number: 3352
• Device Catalogue Number: 3352
• Device Lot Number: 001478200
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 76