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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER GMBH & CO. EMMETT UTERINE PROBE WK LGTH 8-1/2IN SOUND, UTERINE

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KARL LEIBINGER GMBH & CO. EMMETT UTERINE PROBE WK LGTH 8-1/2IN SOUND, UTERINE Back to Search Results
Model Number GL1300
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). On 16sep2016, customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available. Confirmation was also requested from the customer that there was no patient impact associated with reported issue. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Customer stated verbally: probe was broken off during surgery in patient. Additional information received 9/14/16 via email: on (b)(6) we had a malfunction of an emmett uterine probe. The probe broke and the piece had to be retrieved from one of our patient. We would like an investigation done to figure out what contributed to this instrument failure and any recommendation that your company can give to the amount of usage these probes should have before replacement. Please have one of you product reps contact me at the number below to discuss this matter as soon as possible. 3 attempts have been made to gather further information but no responses have been received. Additional information 16sep2016: was product used on the patient: yes; did the failure occur during patient use: yes; was there any patient harm, if yes describe: none that we are aware of at this time; was medical intervention required, if yes describe: yes, it extended the length of the procedure, required fluoroscopy and the patient had to stay overnight; was there any user harm: no harm to user; description of event/ quality issue: uterine probe was being used in an anal fistulotomy case. The probe broke and the tip was retained in the fistula tract. The retained tip (remained in the fistula tract) had to be retrieved by the surgeon under fluoroscopy, extending the procedure time and requiring the patient to stay overnight. Additional information 16sep2016: was product used on the patient: yes; did the failure occur during patient use: yes; was there any patient harm, if yes describe: none that we are aware of at this time; was medical intervention required, if yes describe: yes, it extended the length of the procedure, required fluoroscopy and the patient had to stay overnight; was there any user harm: no harm to user. Description of event/ quality issue: uterine probe was being used in an anal fistulotomy case. The probe broke and the tip was retained in the fistula tract; the retained tip (remained in the fistula tract) had to be retrieved by the surgeon under fluoroscopy, extending the procedure time and requiring the patient to stay overnight.
 
Manufacturer Narrative
(b)(4). The incorrect supplier was initially inadvertently notified and reported on for this complaint. A corrected follow up mdr has been submitted with the correct supplier (b)(4).
 
Manufacturer Narrative
(b)(4) the sample photos were provided and an investigation was performed on the basis of complaint statistics as no device was sent back for evaluation. It is determined that the complaint percentage falls well within the product risk limits that are adhered to at the supplier¿s facility. In addition to no device being returned, device history records could not be reviewed because no lot number or traceable identification to conduct a proper investigation was provided. The picture analyses revealed that the device was bent in multiple points. Due to no device being returned and no lot number provided, the root cause for the failure cannot be determined. Complaint statistics: (b)(4). There are no further actions are possible, since the root cause for the failure cannot be determined.
 
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Brand NameEMMETT UTERINE PROBE WK LGTH 8-1/2IN
Type of DeviceSOUND, UTERINE
Manufacturer (Section D)
KARL LEIBINGER GMBH & CO.
postfach 20
muehlheim an der donau 78568
GM 78568
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8473628063
MDR Report Key5973092
MDR Text Key55468968
Report Number1423507-2016-00065
Device Sequence Number1
Product Code HHM
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGL1300
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/23/2016 Patient Sequence Number: 1
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