MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURGICAL PATTIE, 1/2 X 1/2; SURGICAL SPONGE

Catalog Number 80-1400

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

In the literature article ¿radiographic detectability of retained neuropathies in a cadaver model¿ (2015) 84, 2:405-411, http://dx.Doi.Org/10.1016/j.Wneu.2015.03.032, it was reported that codman neuro patties in sizes ¼ x ¼ and ½ x ½ had in adequate radiopacity.Counts are the commonest method used to ensure that all sponges and neuropathies are removed from a surgical site before closure.When the count is not reconciled, plain radiographs of the operative site are taken to determine whether the missing patty has been left in the wound.The purpose of this study was to describe the detectability of commonly used neuropathies in the clinical setting using digital technologies.Three surgical sites were chosen: the anterior cranial fossa, the posterior cranial fossa, and the thoracolumbar extradural space.Each operative site was draped in the usual manner with drapes being secured with surgical staples to simulate typical intraoperative artifacts.Craniotomies and laminectomies were performed to allow access for the placement of the neuropathies.Neuropathies (the four products tested in our study were, codman (raynham, ma) surgical patties: 80-1399 1/4 _ 1/4 in [64 _ 64 cm]; 80-1400 1/2 _ 1/2 in [1.27 _ 1.27 cm]; 80-1406 1/2 _ 2 in [1.27 _ 5.06 cm]; 80-1408 1 _ 3 in [2.54 _ 7.62 cm]) were implanted in randomized combinations into each surgical site and positioned in clinically relevant subregions as described.Under simulated operating room conditions and using currently available neuropathies and plain radiograph imaging technology, small 1/4-in and 1/2-in neuropathies are poorly visible/detectable on digital images.At the time of complaint entry there are no known lot numbers and the devices are not available for analysis.

• Brand Name: SURGICAL PATTIE, 1/2 X 1/2
• Type of Device: SURGICAL SPONGE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5216980
• MDR Text Key: 30987836
• Report Number: 1226348-2015-10658
• Device Sequence Number: 1
• Product Code: HBN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention