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

Model Number MG096R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.It was reported during a circumcision there was excessive bleeding while using a clamp.It did not clamp down properly to the skin to stop the blood flow.It was also noticed that the plastic ring that is attached to the nut part of the clamp was loose.

Manufacturer Narrative

Request for investigation by the contract manufacturer were made; results were not provided.This device is part of recall number 2916714-10/18/2016-015r.If investigation results are receieved in the future, a follow up report will be provided detailing those results.Investigation report not provided.

• Brand Name: GOMCO CIRCUMCISION CLAMP XTRA SM 11MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• 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: 6064416
• MDR Text Key: 58717774
• Report Number: 2916714-2016-00901
• 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: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MG096R
• Device Catalogue Number: MG096R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/11/2016
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Other