MAUDE Adverse Event Report: LAWTON GMBH & CO KG MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN; CLAMP, CIRCUMCISION

Model Number GL7021

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) on (b)(6) 2016, 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: the clamp does not look like its working properly.The clamp is very loose, too much give.On 07apr2016 additional information: was the product received in this condition? yes, as far as we know it was.We have physicians that have been doing mogen circumcisions for a very long time and just recently within the past 6-9 months we have had some very bad mogen circumcisions as a result of this clamp.If not, what was the product being used for when it was observed that the clamp does not look like its working properly.The clamp is very loose, too much give? while performing circumcisions they have not gone well.Please confirm whether or not there was any patient impact.There have been a few very bad circumcisions due to this mogen clamp.Additional bleeding, too much foreskin being removed, and even a potential for reconstructive surgery with a urology consult occurred with one of the circumcisions.(b)(6) on 14apr2016 additional information: how many patients were involved with the injuries stated? 4 that we know of.Do you know the dates of when these actual events occurred? we would need to contact the physicians to pull the dates- we do know the four different physicians this affected.You mention this has occurred a few times (3?) over the past 6-9 months.Are all three injuries related to one particular instrument, or are there other instruments involved? if so, do you know the lot #s? i sent you both of the mogens that we deemed as not working properly.I do not have the lot numbers as the mogens were sent back last week.(b)(6) on 04/12/2014: lot numbers and quantity updated.On 29apr2016 additional information: the reported issue was increased bleeding: more than usual (for this complaint, (b)(4)).On 04may2016 (b)(4) were opened to capture the additional reported issues mentioned in this complaint, (b)(4).

Manufacturer Narrative

(b)(4).The samples were provided and an evaluation was performed.The instruments were manufactured and inspected without any abnormalities in october of 2011 (lot number xlfo10) and february of 2015 (lot number xlfx02).The instrument with lot number xlfx02 meets all specifications, including closing force at 10.5 n, and no malfunctions or failures were detected.The instrument with lot number xlfo10 now has an unfastened screw.Due to the loose screw, the instrument will not function properly.The loose screw should have been easily recognizable prior to use during an inspection and was caused by long time use.There have been no issues identified with the material or manufacturing process.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): LAWTON GMBH & CO KG; wuerttemberger str.23; fridingen 78567 ; GM 78567
• 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: 5633863
• MDR Text Key: 44483587
• Report Number: 1423507-2016-00055
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GL7021
• Device Lot Number: XLFX02 AND XLFO10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other