MAUDE Adverse Event Report: SURGICAL DESIGN CIRCUMCISION CLAMP, SIZE: 1.3CM; CLAMP, CIRCUMCISION

Catalog Number 32-1622

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

The clamp when tightened cuts through part of the skin.Dr.(b)(4) was performing a circumcision with a 1.3 clamp.As she tightened the clamp, she and the nurse heard a loud pop and the ball had come through the hole in the base, cut through some of the skin and "filleted" or partially cut through other parts of the skin.The physician spent an extra 30 minutes (compared to the time of usual circumcisions) attempting to repair the damage.She was required to use a plastibel and sutures in order to correct the damage.

Manufacturer Narrative

The work order was reviewed for discrepancies.Vendor defects were identified within the work order in reference to the raw material 5-20265 but no additional info is available as to what the identified defects are referencing.Lot mapping identified that lot numbers 1300/650/gc1.S and 120/100613/gci.3cm were utilized.No inspection documentation is available for the identified lot numbers per the mfg facility's qc and the 2013 scar log was reviewed and it was unable to identify that a scar had been issued to surgical design due to the internal findings.Refer to the bp 30 branch plant notification as evidence.The qc complaint specialist contacted the deroyal sales rep in reference to the report and sample availability.It has been identified that rep samples are available for eval and would be returned to deroyal.The actual sample in which the issue occurred will not be returned for eval.A request was sent to the deroyal sales rep to follow up with the reporting customer and obtain pictures of the actual device with reference measurements.The end user has not responded with the requested info.Refer to the email communication between the deroyal sales rep and the qc complaint specialist as evidence.The rep sample was returned for eval on 9/26/2014 and measurements were taken to identify if the product was conforming to drawings 293-08.The bell was measure and found to be conforming to the drawing but was on the lower end of the range.The hole in the foot plate was measured and found to be non-conforming due to being too low on the range.Refer to the call (b)(4) rep sample eval/pictures attachment for evidence.The sample has now been forwarded to surgical design for eval.Scar2014-405kjg has been issued to surgical design in reference to the raw material due to the complaint investigation.The scar due date has been identified as (b)(6) 2014.During the investigation the rep samples were returned to surgical design for eval.The completed scar was returned to deroyal on 10/03/2014.In addition to the scar response, surgical design has supplied detail.

• Brand Name: CIRCUMCISION CLAMP, SIZE: 1.3CM
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): SURGICAL DESIGN; 7351-d lockport pl.; lorton VA 22079
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4265004
• MDR Text Key: 5300904
• Report Number: 2320762-2014-00021
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2018
• Device Catalogue Number: 32-1622
• Device Lot Number: 33890732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention