MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number 3152

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

During the surgery, the heat shrink of the tip came off.We confirmed the heat shrink was completely off and the metal parts were partially exposed.We assume the heat shrink came off due to the contact of the combination instruments.

• Brand Name: RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE
• Type of Device: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 18857214
• MDR Text Key: 337674618
• Report Number: 1223422-2024-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010012
• UDI-Public: 00811099010012
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3152
• Device Catalogue Number: 3152
• Device Lot Number: 00169098
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1