MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513303
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 radial jaw 4 biopsy forceps was unpacked on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was a hair inside the primary package, and sterility of the device was compromised.Reportedly, there was no patient or procedure involved.
Additional Manufacturer Narrative
(b)(6).(b)(4).A box was received with a sealed pouch inside.The pouch was inspected and foreign matter (a hair) was found inside.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.Due to the foreign matter found inside the pouch and as per available information the most probable cause for this complaint is manufacturing deficiency.An investigation has been initiated to address this issue.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 biopsy forceps was unpacked on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was a hair inside the primary package, and sterility of the device was compromised.Reportedly, there was no patient or procedure involved.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7879412
• Report Number: 3005099803-2018-60464
• Device Sequence Number: 19329085
• Product Code: FCL
• UDI-Device Identifier: 08714729761839
• UDI-Public: 08714729761839
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: EXEMPT
• 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): 11/12/2018

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: 05/31/2021
• Device Model Number: M00513303
• Device Catalogue Number: 51420
• Device Lot Number: 0022197943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1