MAUDE Adverse Event Report: CONTRACT MANUFACTURER: SUPERIOR SURGICAL LLC GOMCO CIRCUMCISION CLAMP XTRA SM 11MM

Model Number MG096R

Device Problem Device Issue (2379)

Patient Problem Laceration(s) (1946)

Event Date 06/07/2016

Event Type  Injury  

Event Description

During a circumcision, the foreskin was clamped and torn, possibly due to rough edges in ring of the device.Additional suturing was required, this resulted in a delay.There was no serious injury reported.

Manufacturer Narrative

Device was returned for investigation.Visual inspection determined there were no rough edges on the ring area around the base or the bell edges.The issue is determined to be user related.Recall conducted by aesculap, inc.2916714-10/18/2016-015r.

• Brand Name: GOMCO CIRCUMCISION CLAMP XTRA SM 11MM
• Type of Device: CLAMP
• Manufacturer (Section D): CONTRACT MANUFACTURER: SUPERIOR SURGICAL LLC; 321 jones blvd; pottstown 19464
• Manufacturer (Section G): CONTRACT MANUFACTURER: SUPERIOR SURGICAL LLC; 321 jones blvd; pottstown 19464
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5757075
• MDR Text Key: 48406044
• Report Number: 2916714-2016-00538
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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?: No
• Device Operator: No Information
• Device Model Number: MG096R
• Device Catalogue Number: MG096R
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/08/2016
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other