MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. GOMCO CIRCUMCISION CLAMP

Model Number UNKNOWN

Device Problem Failure to Obtain Sample (2533)

Patient Problem Blood Loss (2597)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

1.We originally talked to (b)(6) who was listed on the report.She referred us to (b)(6), who originally said they would return the clamp for evaluation.We then tried to contact the hospital many times with no response.We finally got a response , which, said they will not be returning the clamp because it was involved in an incident.2.We requested pictures which they also said they could not provide.3.Therefore, we cannot determine the following: a.If the clamp was manufactured by allied hpi b.The age and or how often the clamp was used.C.Condition of the clamp.4.The part number listed on the report is not ours.5.Their report said the clamp was disposable.Our clamp is re-usable.6.This incident was not directly reported to us.We learned of this incident from the fda.7.We do not know if this is a genuine gomco clamp or a copy made by another manufacturer.8.It does not appear that they followed the instructions, which are sent with each allied clamp.Which state: warning: a.This clamp must never be used if component parts are damaged, missing, clearly worn, or the assembled device does not perform as described.B.Prior to initiating the surgical procedure, you must insure that expected clamping function has been properly achieved.C.Important: some bleeding may occur and or some sutures may be required depending on the prescribed surgical technique.

Event Description

It ws reported that a circumcision procedure performed by a physician, a 1.3 gomco was used.When it was time to tighten the clamp, the physician was unable to completely tighten the nut on the threaded post.When physician turned the nut, it would spin around, but, would not move down the threads to tighten the clamp.Due to the inability to completely tighten the clamp during the procedure, additional pressure and silver nitrate were applied by the physician to stop the oozing.After the procedure was completed, the gomco clamp was removed and inspected.A small defect was noted on the threads about midway down the post.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; st. louis MO 63110
• Manufacturer Contact: jon stillman ; 1720 sublette ave.; st. louis, MO 63110 ; 3142681616
• MDR Report Key: 7187317
• MDR Text Key: 97873509
• Report Number: 1924066-2018-00001
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• 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
• Patient Age: 2 DA