MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number M000831125

Device Problems Component Missing (2306); Misfire (2532); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

Surgeon was using the capio during a total vaginal hysterectomy, anterior and posterior colporrhaphy, sacrospinous ligament fixation, and diagnostic cystoscopy.The bullet tip was fired.However, when the device was pulled out, the bullet tip was missing (approximately 3 mm).Per md surgeon, it was unclear if the device was misfired.Second stitch requested and the device fired and was successful.Bullet tip never found - may have been left in pt.

Manufacturer Narrative

Unique device identifier (udi): for type of device: laparoscope, general & plastic surgery.

Event Description

Surgeon was using the capio during a total vaginal hysterectomy, anterior and posterior colporrhaphy, sacrospinous ligament fixation, and diagnostic cystoscopy.The bullet tip was fired.However, when the device was pulled out, the bullet tip was missing (approximately 3 mm).Per md surgeon, it was unclear if the device was misfired.Second stich requested and the device fired and was successful.Bullet tip never found - may have been left in pt.

• Brand Name: CAPIO
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6338937
• MDR Text Key: 67694159
• Report Number: 6338937
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M000831125
• Device Lot Number: 18831921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR