MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RADIAL JAW¿ 4; FORCEPS, BIOPSY, ELECTRIC

Model Number	M00515032
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 hot biopsy forceps was unpacked on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was tear in the device packaging and sterility of the device was compromised.There was no patient or procedure involved.
Additional Manufacturer Narrative
Visual analysis of the returned device found the tyvek of the packaging partially removed, compromising the sterile pouch.On the opened section of the pouch, adhesive was noted, showing evidence that the tyvek was properly attached to the pouch.Evaluation revealed the tyvek of the packaging partially removed, which is evidence that an external force was applied to manipulate it.Therefore, the most probable root cause is "handling damage" since no manufacturing issues were noted and the complaint was caused by handling of the device without direct patient contact.The device history record review found the device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 hot biopsy forceps was unpacked on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was tear in the device packaging and sterility of the device was compromised.There was no patient or procedure involved.

• Brand Name: RADIAL JAW¿ 4
• Common Device Name: FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7258539
• Report Number: 3005099803-2018-00338
• Device Sequence Number: 987886
• Product Code: KGE
• UDI-Device Identifier: 08714729790105
• UDI-Public: 08714729790105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 04/04/2020
• Device Model Number: M00515032
• Device Lot Number: 20492289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/10/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1