MAUDE Adverse Event Report: BOSTON SCIENTIFIC RADIAL JAW 4 LARGE CAPACITY WITH NEED; BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE

Lot Number	18916217
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor doing colonoscopy as doing bx, when clamped down on jaw of forcep noted that needle sticking out to side of forcep, when withdrew bx forcep needle not present.The scope went to sps, run brush through and did not find needle.According to tech the scope was damaged, sps tech stated that evidence of scope puncture present.Reason for use: endoscopy.Is the product compounded? no.Is the product over-the-counter? no.Event abated after use stopped or dose reduced? yes.

• Brand Name: RADIAL JAW 4 LARGE CAPACITY WITH NEED
• Common Device Name: BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5707041
• Report Number: MW5062730
• Device Sequence Number: 18839489
• Product Code: HTD
• UDI-Device Identifier: 08714729745549
• UDI-Public: 08714729745549
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 18916217
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR