MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESCUE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	M00538351
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rescue retrieval forceps was to be used in a procedure on (b)(6) 2020.According to the complainant, during preparation, scratches were found on the side of the white product packaging and was torn out.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: device code 2385 captures the reportable event of torn packaging.Block h10: visual analysis found all the seals external of the box were not broken and the unit was sealed.An indented scrape was found on one side but did not fully puncture the box.The product inside the box was confirned to be not damaged (torn) and the packaging was sealed.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on all available information, it is unlikely that the reported event is due to a manufacturing issue.It is possible that the box was scraped as it was shipped and transported from the manufacture site to the customer.Therefore, the most likely root cause is caused traced to transport/storage, which indicates that problem may be traced to transport or storage of the device.
Event or Problem Description
It was reported to boston scientific corporation that a rescue retrieval forceps was to be used in a procedure on (b)(6) 2020.According to the complainant, during preparation, scratches were found on the side of the white product packaging and was torn out.No patient complications were reported as a result of this event.

• Brand Name: RESCUE
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10581109
• Report Number: 3005099803-2020-04028
• Device Sequence Number: 14101071
• Product Code: OCZ
• UDI-Device Identifier: 26948318968606
• UDI-Public: 26948318968606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 08/28/2021
• Device Model Number: M00538351
• Device Catalogue Number: 3835
• Device Lot Number: 2019082901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1