MAUDE Adverse Event Report: GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE

Model Number PILLCAM SB2 CAPSULE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Case report of a potential complication of video capsule endoscopy.A (b)(6)-year-old man presented to our emergency room with malena and symptoms suggestive of anaemia.He was on chronic anticoagulation with warfarin for a mechanical aortic valve.He was haemodynamically stable.Laboratory investigations revealed a low haemoglobin level of 7.1 g/dl and a low-ferritin level of 6 ng/dl suggesting chronic gastrointestinal bleeding.Oesophagogastroduodendoscopy and colonoscopy were performed to identify the source of bleeding but were unfruitful.Video capsule endoscopy was performed.Fifteen house after ingesting the capsule endoscope, the patient started having severe abdominal pain, nausea and vomiting.Abdominal x-ray did not show any bowel perforation.Ct of the abdomen revealed impaction of the capsule endoscope at the appendiceal orifice and an inflamed appendix.Patient underwent laparoscopic appendectomy and made a good recovery.

• Brand Name: PILLCAM SB2 CAPSULE
• Type of Device: PILLCAM SB2 CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building, new industrial park; p.o. box 258; yokneam 20692 ; IS 20692
• MDR Report Key: 3904179
• MDR Text Key: 4515237
• Report Number: 9710107-2014-00116
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K101250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PILLCAM SB2 CAPSULE
• Device Catalogue Number: FGS-0179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR