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

Model Number	M00513401
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 radial jaw 4 standard capacity biopsy forceps was unpacked on (b)(6) 2019.According to the complainant, during unpacking, the device packaging was found damaged and sterility of the device was compromised.The procedure was completed with another radial jaw 4 standard capacity biopsy forceps.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was unpacked on (b)(6) 2019.According to the complainant, during unpacking, the device packaging was found damaged and sterility of the device was compromised.The procedure was completed with another radial jaw 4 standard capacity biopsy forceps.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem code 1444 captures the reportable event of packaging seal compromised.Block h10: the device was returned within its pouch.Visual analysis found the returned device was in good condition.The device pouch was opened: it had been cut or ripped along the pouch's markings that indicate where to open the package.The cut was irregular and did not appear to be a mechanical cut.The pouch's seal was in good condition.There were no other issues noted.The complainant's report that the packaging was damaged and the sterility of the device was compromised was confirmed: the returned packaging was cut/ripped open.The cut/rip appeared to be intentional.During manufacturing, all pouches are inspected for damaged.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.Therefore, the most probable cause of the event is "cause traced to transport/storage".

• 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: 8684684
• Report Number: 3005099803-2019-02910
• Device Sequence Number: 16711486
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: Health Professional
• Device Expiration Date: 07/20/2021
• Device Model Number: M00513401
• Device Catalogue Number: 1340
• Device Lot Number: 0022409645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 58