MAUDE Adverse Event Report: BOSTON SCIENTIFIC ACCUMAX 200

Catalog Number M0068404012

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2015

Event Type  malfunction  

Event Description

During right ureteroscopy with laser lithotripsy, the tip of the laser fiber fragmented off and was not visible for the surgeon to retrieve, but there was a large access ureteral sheath in place for flushing stone fragments out and may have flushed out with those fragments.

• Brand Name: ACCUMAX 200
• Type of Device: ACCUMAX 200
• Manufacturer (Section D): BOSTON SCIENTIFIC; 32 hampshire road; NH 03079
• MDR Report Key: 5327148
• MDR Text Key: 34437014
• Report Number: MW5058718
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2018
• Device Catalogue Number: M0068404012
• Device Lot Number: C000002370
• Other Device ID Number: (01)08714729784623(17)180904(1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 98