MAUDE Adverse Event Report: GIVEN GILA (LOS. ANGELES) MANOSCAN ESO Z CATHETER; SYSTEM, GASTROINTESTIONAL MOTILITY(ELECTRICAL)

Model Number 3890

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient required unintended radiation exposure.

Event Description

According to the reporter, the esophageal manometry probe was placed during esophagogastroduodenoscopy.Manometry study was conducted without incident.Upon removal of the esophageal manometry probe, the probe was stuck and unable to be removed.Several attempts were made to dislodge the probe.The doctor was notified and assessed the patient.The doctor tried to remove the probe, but was unsuccessful.Doctor spoke with the doctor who placed the manometry probe during esophagogastroduodenoscopy.The patient was brought to radiology for chest x-ray to assess probe placement.The doctors from ears, nose, and throat (ent) came to assess probe placement in gi clinic.The doctor from ent was also unable to remove probe while in the clinic.The patient was brought up to ent clinic where the probe was removed successfully.The patient suffered a small nose bleed which was noted and stopped by the time the patient left the clinic.After the procedure, it was determined the patient had an anatomical abnormality that may have contributed to the probe being stuck.Patient safety did follow up with risk management at the hospital for how the probe was removed and additional information could not be provided.

Manufacturer Narrative

Evaluation summary: the device was returned for evaluation, and a device history review showed that it was released meeting finished product specification.It was noted following the procedure that the issue was caused by an anatomical anomaly in the patient, though the customer stated that no specific details were available regarding the abnormality.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MANOSCAN ESO Z CATHETER
• Type of Device: SYSTEM, GASTROINTESTIONAL MOTILITY(ELECTRICAL)
• Manufacturer (Section D): GIVEN GILA (LOS. ANGELES); 5860 uplander way; culver city CA 90230
• Manufacturer (Section G): GIVEN GILA (LOS. ANGELES); 5860 uplander way; culver city CA 90230
• Manufacturer Contact: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 6154279
• MDR Text Key: 61718946
• Report Number: 3005344223-2016-00005
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3890
• Device Catalogue Number: 3890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention