MAUDE Adverse Event Report: CONTRACT MANUFACTURER: SUPERIOR SURGICAL LLC GOMCO CIRCUMCISION CLAMP NEWB 13MM; GENERAL SURGICAL INSTRUMENTS

Model Number MG097R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaints: usa.It was reported that during a circumcision, the device has a loose fitting issue around the bell, which results in inadequate compression of the foreskin.This resulted in excessive bleeding and a poor outcome for the patients on four separate occasions.The clamp was left in place for an additional 5 minutes, but the bleeding was consistent.Harm to patients was excessive bleeding and poor outcome.Delay in surgeries are unknown.All med watch submissions related to this report are: 2916714-2016-00902, 2916714-2016-00903, 2916714-2016-00904, 2916714-2016-00905.

Manufacturer Narrative

The investigation of the reported issue determined that the device was improperly used.Recall of device conducted under recall number 2916714-10/18/2016-015r.

• Brand Name: GOMCO CIRCUMCISION CLAMP NEWB 13MM
• 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: 6077715
• MDR Text Key: 59132756
• Report Number: 2916714-2016-00903
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MG097R
• Device Catalogue Number: MG097R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/27/2016
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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