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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES LLC MANOSCAN; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
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GIVEN IMAGING LOS ANGELES LLC MANOSCAN; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) Back to Search Results
Model Number 3890
Device Problem Difficult to Remove (1528)
Patient Problems Sedation (2368); Sore Throat (2396); Blood Loss (2597); No Information (3190)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the catheter was stuck in the patient.There was no reported patient outcome.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
According to the reporter, the catheter was stuck in the patient.The physician sedated the patient and cut the catheter to dislodge it from the patient¿s nostrils.The patient experienced nose bleed and sore throat.The customer stated that the catheter worked correctly during the previous procedure.
 
Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product was received for evaluation.The returned sample did not meet specification as received by medtronic.The visual inspection found the silicone sleeve is damaged.The silicone sleeve is bunching at the strain relief carrier.The catheter is cut at 62 cm mark.The reported condition was confirmed.The investigation found the catheter could not be calibrated or tested on pico scope.The investigation found the most probable cause to be the silicone sleeve damage.The probable root cause was found to be user mishandling.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MANOSCAN
Type of Device
SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
Manufacturer (Section D)
GIVEN IMAGING LOS ANGELES LLC
5860 uplander way
culver city CA 90230
MDR Report Key9638885
MDR Text Key176658687
Report Number3005344223-2020-00002
Device Sequence Number1
Product Code FFX
UDI-Device Identifier04260167482446
UDI-Public04260167482446
Combination Product (y/n)N
PMA/PMN Number
K151086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3890
Device Catalogue Number3890
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Date Manufacturer Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age66 YR
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