MAUDE Adverse Event Report: UNKNOWN GOMCO; CLAMP, CIRCUMCISION

Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/20/2017

Event Type  malfunction  

Event Description

During circumcision, two gomco sets were opened.Both were a 1.1cm gomco, but a 1.3cm bell was inside one of them.Doctor used the 1.3cm bell but when she attempted to apply the clamp, it would not allow her to screw the top on (it did not fit).It was then that it was discovered that the bell and the clamp were two different sizes.The clamp had to be removed and an additional circumcision set was opened to get the right size clamp.There was increased bleeding with the circumcision, unsure if related to increased manipulation or anatomic factors.

• Brand Name: GOMCO
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7078676
• MDR Text Key: 93590925
• Report Number: 7078676
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.