MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX LOCKING DEVICE; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00545211
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device package 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device biopsy cap was inspected at the distributor on (b)(6) 2019.According to the complainant, during unpacking of the outer box at the distributor, it was noted that the device packaging was found torn.There was no patient nor procedure involved in this event.
Additional Manufacturer Narrative
Block h6: device code 2385 captures the reportable event of the packaging torn.Block h10: an rx biopsy cap was received, in its original box, for analysis.A visual evaluation of the returned device revealed that the closure strip on the top of the box was still sealed/intact.The box had signs of handling and manipulation.It was found wrinkled in some areas and the perforated portion of the device box was opened.No other issues were noted.Based on the information available and the analysis performed, it is most likely that handling and manipulation of the device during transport or storage could have contributed with the encountered issues.Manipulation of the device can lead to damage of the box/package during transport or storage.Therefore, the most probable cause for this event is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device biopsy cap was inspected at the distributor on april 1, 2019.According to the complainant, during unpacking of the outer box at the distributor, it was noted that the device packaging was found torn.There was no patient nor procedure involved in this event.

• Brand Name: RX LOCKING DEVICE
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8544522
• Report Number: 3005099803-2019-02126
• Device Sequence Number: 2458055
• Product Code: KOG
• UDI-Device Identifier: 08714729440604
• UDI-Public: 08714729440604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: Other
• Device Expiration Date: 02/10/2023
• Device Model Number: M00545211
• Device Catalogue Number: 4521
• Device Lot Number: 0023326422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1