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

Catalog Number 80-1404

Device Problems Component Missing (2306); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is not clear at this point if the device is available 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.Device not available.

Event Description

As reported by the ous affiliate, a 10 pk of codman patties contained 11.One of the patties was missing a string.Event occurred before the surgery commenced.Another lot was used to complete the surgery.There were no reports of delay or patient harm.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Product sample was received and a pattie miscount confirmed.11 of 10 patties present.1 of the 11 patties is missing the string.A review of the device history record found no discrepancies when the device was released to stock.Root cause is likely 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 amount of 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.It is likely that an additional pattie was left in the stack.If the pattie were missing the string, it would not be detected in the count.Trends will be monitored for this or similar complaints.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: 7235862
• MDR Text Key: 98995668
• Report Number: 1226348-2018-10098
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1404
• Device Lot Number: HD2230 / W133040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1