MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG; IRRIGATION TUBING SET, GENERAL PURPOSE

Catalog Number 80-1189

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been reported that the device will not be returned for evaluation.A lot number has been provided.Upon completion of the manufacturing review, a follow-up report will be submitted.

Event Description

It was reported that leakage was noted during preparation before the surgery.The location of hole is unknown.The used generator¿s type is unknown.User training is scheduled to be done.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The product will not be returned to your site.

Manufacturer Narrative

The device was returned for evaluation.The tube set was visually examined.There was a hole in the connection area/silicone-pumping segment.The hole was found in the silicone tubing and is aligned with end of the bottom connector.The actual damage is consistent with the abrasion that can occur when loading the tube set at either the upper or bottom slots of the irrigation unit.During loading of the tube sets, abrading the silicone tubing at the tube/connector transition point is possible if the tube set is loaded into the irrigation unit improperly.The hole is consistent with the use of a ji2000, which is not recommended for use with this tubing set.A review of the dhr did not show any anomalies during the manufacturing process.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The product was subsequently returned.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG
• Type of Device: IRRIGATION TUBING SET, GENERAL PURPOSE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7375193
• MDR Text Key: 103700465
• Report Number: 1226348-2018-10238
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K890648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1189
• Device Lot Number: HD6250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1