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

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.

• Brand Name: EMMETT UTERINE PROBE WK LGTH 8-1/2IN
• Type of Device: SOUND, 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 Key: 5973092
• MDR Text Key: 55468968
• Report Number: 1423507-2016-00065
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• 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 Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GL1300
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other