MAUDE Adverse Event Report: ANREI MEDICAL RESCUE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	M00527451
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code: a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a box of the rescue retrieval forceps was received and unpacked on an unknown date.During unpacking, the seal of the product pouch was peeled off and the box was flattened.There was no procedure nor patient involved during this event.
Additional Manufacturer Narrative
Report number 3005099803-2024-01850 was submitted in error.Boston scientific corporation does not have a regulatory/contractual obligation to report for the rescue device.The manufacturer, anrei medical, has the regulatory/contractual obligation to report.B3: approximated based on the date the manufacturer became aware of the event.Imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a box of the rescue retrieval forceps was received and unpacked on an unknown date.During unpacking, the seal of the product pouch was peeled off and the box was flattened.There was no procedure nor patient involved during this event.

• Brand Name: RESCUE
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): ANREI MEDICAL; no. 3 ave. 8, heda; hangzhou ; CH
• Manufacturer (Section G): ANREI MEDICAL (HZ); no 3 ave 8 heda; hangzhou, 130 31001 8; CH 310018
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19152597
• Report Number: 3005099803-2024-01850
• Device Sequence Number: 8434503
• Product Code: OCZ
• UDI-Device Identifier: 26948318968613
• UDI-Public: 26948318968613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 08/08/2025
• Device Model Number: M00527451
• Device Catalogue Number: 2745
• Device Lot Number: 2023080901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown