MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW RATCHETED HANDPIECE, 42 CM, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3915
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently being performed by the hospital's risk management department.If the device is returned to microline surgical, inc.Further investigation will be performed and additional information will be provided.
Event or Problem Description
Distal portion of black insulation of renew handpiece cracked into multiple segments and fell off and into patient abdomen during procedure.Some of the insulation was retrieved, however not all was able to be found or recovered from abdomen as stated by staff at the time of incident.Surgeon attempted to recover all portions of insulation but was not able to.

• Brand Name: RENEW RATCHETED HANDPIECE, 42 CM, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 9171872
• Report Number: 1223422-2019-00026
• Device Sequence Number: 14056831
• Product Code: GEI
• UDI-Device Identifier: 00811099010586
• UDI-Public: 00811099010586
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• 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 Model Number: 3915
• Device Catalogue Number: 3915
• Device Lot Number: 00132734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention