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

Model Number M00538351

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10581109
• MDR Text Key: 208373799
• Report Number: 3005099803-2020-04028
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 26948318968606
• UDI-Public: 26948318968606
• Combination Product (y/n): N
• PMA/PMN Number: K101298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1