MAUDE Adverse Event Report: G.A. SURGICAL DEROYAL; FHA - CLAMP, PENILE

Catalog Number 32-1622

Device Problem Product Quality Problem (1506)

Patient Problem Blood Loss (2597)

Event Date 01/03/2014

Event Type  Injury  

Event Description

The hospital reported excess bleeding occurred during use of the circumcision clamp.

Manufacturer Narrative

Describe event or problem: the hospital reported excess bleeding occurred during use of the circumcision clamp.Deroyal: the supplier's investigation determined that lots were built out of specification, resulting in the potential for the device to not clamp the surgical site properly.Deroyal had made a one time purchase from (b)(4) and has determined to conduct a voluntary recall of all product purchased from them.Any product remaining in inventory has been quarantined for destruction, and initial recall letters have been sent to affected customers.

• Brand Name: DEROYAL
• Type of Device: FHA - CLAMP, PENILE
• Manufacturer (Section D): G.A. SURGICAL; sialkot ; PK
• Manufacturer Contact: courtney rinehart ; 200 debusk ln.; powell, TN 37849 ; 8653162122
• MDR Report Key: 3625116
• MDR Text Key: 16686691
• Report Number: 2320762-2014-00004
• Device Sequence Number: 1
• Product Code: FHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Catalogue Number: 32-1622
• Device Lot Number: 33444071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2014
• Date Manufacturer Received: 01/10/2014
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other