MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID

Catalog Number 80-1403

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

It is not clear at this point if the device is available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device 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.

Manufacturer Narrative

Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the samples returned and visually inspected. 1 pattie was confirmed to be missing the string. It appears to have but cut or sliced as the welded section of the string remained on the pattie. The remaining 9 pattie samples were pull tested by a certified operator. All samples passed and were measured between 2 and 5 lbs. The manufacturing lot traveler was pulled and reviewed for lot h33029l-2. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the samples returned and visually inspected. 1 pattie was confirmed to be missing the string. It appears to have but cut or sliced as the welded section of the string remained on the pattie. The remaining 9 pattie samples were pull tested by a certified operator. All samples passed and were measured between 2 and 5 lbs. The manufacturing lot traveler was pulled and reviewed for lot h33029l-2. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.

Manufacturer Narrative

(b)(4). Upon completion of the investigation, a follow up report will be filed.

Event Description

As reported by the ous affiliate, a surgical pattie did not have the green string attached. No reported patient/user harm.

• Brand Name: CODMAN SURGICAL PATTIE
• Type of Device: PADDIE, COTTONOID
• 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: 6891546
• MDR Text Key: 247443501
• Report Number: 1226348-2017-10696
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 80-1403
• Device Lot Number: H33029L-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial