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

Catalog Number 32-1622

Device Problem Product Quality Problem (1506)

Patient Problem Blood Loss (2597)

Event Date 12/20/2013

Event Type  Injury  

Event Description

The medical center reported that the gomco bells seem to be defective.They have been experiencing an increase in newborns bleeding post circumcision because the bell does not clamp properly.

Manufacturer Narrative

Describe event or problem: the medical center reported that the gomco bells seem to be defective.They have been experiencing an increase in newborns bleeding post circumcision because the bell does not clamp properly.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 products 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 (PVT) LTD; sialkot 5131 0; PK 51310
• Manufacturer Contact: courtney rinehart ; 200 debusk lane; powell, TN 37849 ; 8653622122
• MDR Report Key: 3608591
• MDR Text Key: 4171787
• Report Number: 2320762-2014-00001
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2013
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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