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

Catalog Number 80-1404

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the sample.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the ous affiliate, a 10pk of codman patties contained 11.There were no reports of delay or patient harm.

Manufacturer Narrative

The lot number has been provided.Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Udi : (b)(4).Corrected field: device available for evaluation.It was previously reported that the device would be returned.It was later communicated that the sample would not be provided.This report has been updated to reflect the corrected information.The device was not returned for evaluation; however, a photo of the product was provided.Based on the image provided, the reported miscount could be confirmed.The likely root cause is operator error.Upon startup, hybrid machines produce a single sample pattie which is missing a string.This pattie is meant to be discarded.This pattie was likely not discarded and the next stack of 10 was placed over this pattie, per the requirements of the specification, the operator is required to inspect the front and back of the patties and also count the surgical patties.Operators are trained to wrap each string onto a counting card for visibility.The operator then confirms that there are only 10 surgical patties on the card.In this circumstance an additional pattie was left in the stack.Because the pattie was missing the string it was not detected in the count.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN SURGICAL PATTIE
• Type of Device: PADDIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7565390
• MDR Text Key: 110578131
• Report Number: 1226348-2018-10380
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1404
• Device Lot Number: HD2231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1